Mitral valve prosthesis delivery system

ABSTRACT

A heart valve prosthesis delivery system can include a first sheath, a second sheath, a check valve, a check valve control lines, and a heart valve prosthesis carried within the first sheath or the second sheath. The check valve can be carried within the first sheath or the second sheath. The check valve has a check valve frame and a cover component, and the check valve control lines can be coupled to the check valve frame and configured to be manipulated by a physician to control release of the check valve. In use, the check valve can be configured to be deployed within the native valve structure for minimizing back flow of blood during placement of the valve prosthesis when the native valve leaflets are rendered non-functional by the presence of the delivery system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/344,486, filed Nov. 4, 2016, which claims the benefit of U.S.Provisional Application No. 62/252,390, filed Nov. 6, 2015, theentireties of each of which is incorporated herein by reference.

BACKGROUND Field of the Inventions

The present disclosure relates to devices and methods for thepercutaneous delivery and implantation of a cardiac valve prosthesis.The valve prosthesis can be delivered in a collapsed state within asheath to the valve and released in situ.

Description of the Related Art

The mitral valve, also referred to as the left atrioventricular orbicuspid valve, has two primary leaflets, the anterior and posteriorleaflets, and a subvalvular apparatus consisting of chordae tendineaeattaching to the anterior and posterior papillary muscles of the leftventricle. A healthy mitral valve allows blood to flow unimpeded fromthe left atrium to the left ventricle during diastole and preventsregurgitation during systole. Normal mitral valve function depends notonly on the integrity of the underlying valvular structure, but on theadjacent myocardium as well.

There are three types of mitral valve disease: mitral stenosis, mitralregurgitation and mitral valve prolapse. Mitral stenosis refers to thenarrowing of the mitral valve orifice, thereby impairing the filling ofthe left ventricle in diastole. Mitral regurgitation is leakage of bloodfrom the left ventricle backwards into the left atrium during systole.Mitral valve prolapse is the systolic billowing of one or both mitralleaflets into the left atrium during systole.

If the mitral valve becomes diseased or damaged, it may be surgicallyrepaired to restore function. In many cases, however, the valve is toodamaged to permit repair and the valve must be replaced with aprosthetic (artificial) valve. Currently open heart surgical repair andreplacement of the mitral valve are the two main options to treat mitralregurgitation. Open chest mitral valve replacement has been used totreat patients with mitral valve regurgitation since the 1960s. Thepatient's diseased mitral valve is replaced by either a mechanical or abioprosthetic valve. Open heart surgical procedure needs surgicalopening of the thorax, the initiation of extra-corporeal circulationwith a heart-lung machine, stopping and opening the heart, excision andreplacement of the diseased valve, and restarting of the heart. Whilevalve replacement surgery typically carries a 1-4% mortality risk inotherwise healthy persons, a significantly higher morbidity isassociated to the procedure largely due to the necessity forextra-corporeal circulation. Further, open-heart surgery is often poorlytolerated in elderly patients.

Percutaneous approaches to mitral valve repair have been developed toreduce the clinical disadvantages of the open-heart procedures. In somepercutaneous techniques, a prosthesis is advanced in a catheter throughthe patient's vasculature to the vicinity of the mitral valve. Thesetranscatheter techniques include transfemoral delivery in which a deviceis implanted through the femoral artery and transapcial in whichimplantation is through a small incision in the chest and through theapex of the heart. These percutaneous techniques are attractivealternatives to conventional surgical treatment because they do notrequire open-heart surgery or extracorporeal circulation, and can beused in a closed and beating heart. The treatment is potentially lessmorbid and can be applied to a wider range of patients including thosewith less severe valvular dysfunction.

Transcatheter or percutaneous mitral valve replacement is particularlydemanding technically, primarily due to the complex mitral valve andsubvalvular anatomy, the absence well-structured implant site, the oftenmultifactorial coinciding etiologies in mitral valve diseases, and thefrequent occurrence of mitral valve annulus prolapse. Current techniquesof transcatheter mitral valve repair still have a high percentage ofprocedural failures or complications. Their long-term efficiency isrelatively low in particular because of a high rate of recurrent mitralregurgitation. Significant challenges therefore remain for transcathetermitral valve replacement and consequently and despite a particularlyinvasive side, surgical repair is the treatment usually recommended fordiseases of the mitral valve.

The foregoing examples of the related art and limitations relatedtherewith are intended to be illustrative and not exclusive. Otherlimitations of the related art will become apparent to those of skill inthe art upon a reading of the specification and a study of the drawings.

SUMMARY

The following aspects and embodiments thereof described and illustratedbelow are meant to be exemplary and illustrative, not limiting in scope.

In some embodiments, a valve prosthesis can comprise an anchoringelement. The anchoring element can comprise at least one engagementmember. Optionally, the anchoring element can comprise at least one lobeor at least one hook.

Optionally, the valve prosthesis can also comprise a valve component.The valve component can comprise a valve frame that can be radiallyexpandable and comprise a plurality of flexible prosthetic leafletsattached thereto.

In some embodiments, the anchoring element can be flexibly connected tothe valve component such that the anchoring element can move relative tothe valve component along the axis along an inflow-outflow direction(e.g., along a longitudinal axis).

The anchoring element can be flexibly connected to the valve componentthrough a coupler component which can provide a pre-defined maximumdistance by which the anchoring element and the valve component may beseparated along the longitudinal axis and the length of overlap betweenthe anchoring element and the valve component along the longitudinalaxis.

In some embodiments, the valve component can comprise a plurality ofprosthetic valve leaflets attached to thereto the valve frame. In someembodiments, the valve frame can be comprised of a shape memory metal.In some embodiments, the valve frame has a circular cross-section whenin an expanded configuration.

In some embodiments, the anchoring element can comprise a shape memorywire and the anchoring element can expand radially from a collapsedconfiguration to an expanded configuration. In some embodiments, theshape memory wire has a diameter ranging from about 0.5 mm to about 3mm, about 0.5 mm to 2 mm, 1 mm to 3 mm, or 1 mm to 2 mm.

In some embodiments, the anchoring element can comprise an anterior lobeand a posterior lobe. In some embodiments, the anchoring element has alongitudinal axis and a radial axis orthogonal to the longitudinal axis.In the expanded configuration, the anterior lobe can extend upward fromthe radial at an angle ranging from about 70 degrees to about 90degrees, about 80 degrees to about 90 degrees, about 75 degrees to about85 degrees, or about 80 degrees to about 85 degrees. The posterior lobecan extend downward from the radial axis at an angle ranging from about30 degrees to about 45 degrees, about 35 degrees to about 45 degrees, orabout 35 degrees to about 40 degrees. In some embodiments, the anteriorlobe in an expanded configuration in the native valve annulus can exertpressure against the anterior wall of the left atrium and the posteriorlobe in an expanded configuration in the native valve annulus can exertpressure against the posterior wall of the left atrium.

In some embodiments, the anchoring element can comprise 2, 3, 4, 5, 6,7, 8, 9, 10, or between 2-10, 2-8, 3-20, 3-20, 3-8, 3-5, or 3-4 lobes.

In some embodiments, the anchoring element can comprise 2, 3, 4, 5, 6,7, 8, 9, 10, or between 2-20, 2-10, 2-8, 3-20, 3-20, 3-8, 3-5, or 3-4engagement members, such as hooks. In some embodiments, the number ofengagement members or hooks can equal the number of lobes in theanchoring element.

In some embodiments, the anchoring element can comprise an upper supportand a lower support. The upper and lower supports can be coupledtogether by a flexible connector. The flexible connector can comprise atubular skirt that can provide a seal and prevent regurgitation orleakage around the valve prosthesis.

Optionally, the upper support of the anchoring element can form a shapethat permits the upper support to approximate the shape of a nativemitral valve annulus.

In some embodiments, the upper support of the anchoring element cancomprise a first hook positioned between the anterior lobe and theposterior lobe. In some embodiments, the anchoring element can comprisea second hook that can be positioned between the anterior lobe and theposterior lobe and along the radial axis that can be opposite the firsthook.

In some embodiments, the at least two engagement members can comprisethe first hook and the second hook, and the first hook and the secondhook can be separated by a distance of between about 30 mm to about 90mm. In some embodiments, the distance can be approximately equal to thedistance between anterolateral commissure and posteromedial commissureof a heart of the patient who is the recipient of the valve prosthesis.

In some embodiments, the anchoring element can comprise a third hookthat that can be positioned midway along the posterior lobe. In someembodiments, an arm portion of each hook in an expanded configurationextends approximately downward from the radial axis of the anchoringelement.

In some embodiments, the valve prosthesis can further comprise a couplercomponent that interconnects the anchoring element with the valvecomponent. The distance which the anchoring element can move relative tothe valve component can be determined by the length of a couplercomponent. In some embodiments, the coupler component can be fixed tothe valve component. In some embodiments, the coupler component can befixed to the anchoring element.

In some embodiments, the coupler component can comprise a fabric sheet,a suture, and/or a tubular cloth. Optionally, the fabric sheet can be ina tubular configuration. In some embodiments, a first end of the fabricsheet can be attached to the anchoring element and a second end of thefabric sheet can be attached to the valve component. In someembodiments, the fabric sheet can be continuous and extends from thefirst end attached the anchoring element to the second end attached tothe valve component. In some embodiments, the fabric sheet can coverabout one-half to one-third of the length of the valve component. Insome embodiments, the fabric sheet covers about one-third to two-thirds,one-quarter to two-quarters, or the full length of the valve component.In some embodiments, the fabric sheet allows some blood flow through thesheet.

In some embodiments, the coupler component can be comprised of one ormore sutures or thread-like elements, wherein a first end of the one ormore sutures or thread-like elements can be attached to the anchoringelement and a second end of the one or more sutures or thread-likeelements can be attached to the valve component.

In some embodiments, the coupler component can have a length l whichallows the anchoring element to be serially displaced from the valvecomponent when both the anchoring element and the valve component are ina collapsed configuration.

For example, some embodiments of the valve prosthesis can be based onthe anatomy of the mitral annulus. The annulus has a saddle-shaped ringof tissue that surrounds the two leaflets of the mitral valve. An uppersupport of the anchoring element can comprise a D-shaped nitinol ring.The D-shape of the upper support can allow the anchoring element toconform to the annulus with the flat face of the “D” sitting adjacent tothe aortic mitral curtain. The lower support can comprise a nitinol ringhaving three hooks extending from strategic positions matching thenative valve leaflets. Two of the hooks can be positioned to latch inthe commissures (on the ventricular side of the heart) and a third hookcan catch the P2 scallop of the posterior leaflet (also on theventricular side). Further, a flexible connector or tubular skirt canextend between the upper and lower supports. Furthermore, a couplercomponent can interconnect the anchoring element with the valvecomponent.

Accordingly, some embodiments can advantageously provide a seal for theprosthetic valve. For example, the skirt of some embodiments can providea seal for the prosthetic valve without introducing a left ventricularoutflow tract obstruction. The skirt can also prevent paravalvularleakage that can occur, in particular, at commissure locations. Theskirt can also aid in ingrowth to enhance sealing.

In some embodiments, a valve prosthesis delivery system can be provided.The delivery system can comprise a first sheath and a second sheath. Thefirst sheath and the second sheath can be positioned longitudinallyadjacent to one another or in an end-to-end abutting relationship alongthe longitudinal axis. The delivery system can optionally compriseanchor controls, graspers, or anchor control sleeves that can engagewith at least a portion of a valve prosthesis supported by or carried bythe delivery system.

In accordance with some embodiments, the valve prosthesis can bedelivered to the native mitral valve annulus in a collapsedconfiguration in which the valve component and anchoring element areserially (or longitudinally spaced relative to each other), rather thanconcentrically positioned relative to one another, thereby minimizingthe diameter of the valve prosthesis and therefore, minimizing thediameter of the delivery system during delivery.

In some embodiments, the delivery system can further comprise a controlunit, wherein the control unit can be used by a surgeon or medicalphysician to independently manipulate at least lateral or rotationalmovements of at least the valve prosthesis, anchor controls, the firstsheath, and/or the second sheath.

In some embodiments, the first sheath can enclose the valve component,and the second sheath can enclose the anchoring element. The firstsheath can be adjacent to and distal to the second sheath.

However, in some embodiments, the first sheath can enclose the anchoringelement, and the second sheath can enclose the anchoring element. Thefirst sheath can be adjacent to and distal to the second sheath. In someembodiments, the valve component can be flexibly connected to theanchoring element.

In some embodiments, the number of anchor controls can be equal to thenumber of engagement members or hooks of the anchoring element. Further,the proximal end of each of the anchor controls can be coupled to thecontrol unit and a distal end of each of the anchor controls can bereleasably coupled to one of the hooks.

In some embodiments, the delivery system can further comprise a firstsheath shaft connected at its distal end to the first sheath and at itsproximal end to the control unit.

In some embodiments, the delivery system can further comprise a counternose cone, wherein the counter nose cone can be positioned between thefirst and second sheaths. For example, the counter nose cone canmaintain the position of the valve component within the first sheath orthe second sheath prior to full release of the valve prosthesis.

In some embodiments, a method can be provided for transapical deliveryof a mitral valve prosthesis comprising use of the delivery system asdescribed above.

In some embodiments, the method can comprise inserting the distal end ofthe delivery system into the left ventricle and advancing the firstsheath through the mitral valve into the left atrium. The second sheathcan be moved in a proximal direction such that an upper support of theanchoring element expands radially to contact the anterior and posteriorsurfaces of the left atrium and a lower support of the anchoring elementexpands radially to contact papillae and/or the left ventricle wall. Theanchoring element can then be moved in a proximal direction until thelower support and the upper support are on opposite sides of the nativemitral valve annulus. Thereafter, the first sheath can be moved in adistal direction while holding the valve component stationary to releasethe valve component. The valve component can expand in a radialdirection within the anchoring element. Thereafter, the delivery devicecan be removed by pulling the first and second sheaths in a proximaldirection.

Additional embodiments of the present devices and methods, and the like,will be apparent from the following description, drawings, examples, andclaims. As can be appreciated from the foregoing and followingdescription, each and every feature described herein, and each and everycombination of two or more of such features, is included within thescope of the present disclosure provided that the features included insuch a combination are not mutually inconsistent. In addition, anyfeature or combination of features may be specifically excluded from anyembodiment of the present disclosure. Additional aspects and advantagesof the present disclosure are set forth in the following description andclaims, particularly when considered in conjunction with theaccompanying examples and drawings.

Additional features and advantages of the subject technology will be setforth in the description below, and in part will be apparent from thedescription, or may be learned by practice of the subject technology.The advantages of the subject technology will be realized and attainedby the structure particularly pointed out in the written description andembodiments hereof as well as the appended drawings.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and areintended to provide further explanation of the subject technology.

BRIEF DESCRIPTION OF THE DRAWINGS

Various features of illustrative embodiments of the inventions aredescribed below with reference to the drawings. The illustratedembodiments are intended to illustrate, but not to limit, theinventions. The drawings contain the following figures:

FIG. 1 is a cross-sectional view of a heart, illustrating aspects of theheart.

FIG. 2 is a side cross-sectional view of a mitral valve prosthesisimplanted in the heart, according to some embodiments.

FIG. 3 is a bottom cross-sectional view of the mitral valve prosthesisof FIG. 2, implanted in the heart, according to some embodiments.

FIG. 4 is a top cross-sectional view of the mitral valve prosthesis ofFIG. 2, implanted in the heart, according to some embodiments.

FIG. 5 shows an embodiment of the valve component and the anchoringelement of a mitral valve prosthesis in a non-engaged configuration,according to some embodiments.

FIG. 6 shows an embodiment of a mitral valve prosthesis in aconfiguration when released in a mitral valve annulus, according to someembodiments.

FIGS. 7A and 7B illustrate top and perspective views of a valvecomponent of a mitral valve prosthesis, according to some embodiments.

FIGS. 8A and 8B illustrate top and perspective views of an anchoringelement of a mitral valve prosthesis, according to some embodiments.

FIGS. 9A and 9B illustrate bottom and perspective views of a mitralvalve prosthesis having first and second skirts, according to someembodiments.

FIGS. 10A-10C illustrate a mitral valve prosthesis, according to someembodiments.

FIGS. 11A-11C illustrate a valve prosthesis delivery device, accordingto some embodiments.

FIG. 12 illustrates a check valve that can be delivered using a deliverysystem, according to some embodiments.

FIGS. 13-19 illustrate aspects of methods for delivering a valveprosthesis using a delivery system, according to some embodiments.

FIGS. 20A-21B illustrate optional anchoring elements, according to someembodiments.

FIG. 22 shows another embodiment of a valve component and an anchoringelement of a mitral valve prosthesis in a non-engaged configuration,according to some embodiments.

FIG. 23 shows the mitral valve prosthesis of FIG. 22 in a configurationwhen released in a mitral valve annulus, according to some embodiments.

FIG. 24 shows yet another embodiment of a valve component and ananchoring element of a mitral valve prosthesis in a non-engagedconfiguration, according to some embodiments.

FIG. 25 shows the mitral valve prosthesis of FIG. 24 in a in aconfiguration when released in a mitral valve annulus, according to someembodiments.

FIG. 26 illustrates aspects of optional methods for delivering a valveprosthesis using a delivery system, according to some embodiments.

FIG. 27 illustrates aspects of optional methods for delivering a checkvalve, according to some embodiments.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are setforth to provide a full understanding of the subject technology. Itshould be understood that the subject technology may be practicedwithout some of these specific details. In other instances, well-knownstructures and techniques have not been shown in detail so as not toobscure the subject technology.

Further, while the present disclosure sets forth specific details ofvarious embodiments, it will be appreciated that the description isillustrative only and should not be construed in any way as limiting.Additionally, it is contemplated that although particular embodiments ofthe present disclosure may be disclosed or shown in the context ofmitral valve prostheses, such embodiments may be used in other cardiacvalve prosthesis applications. Furthermore, various applications of suchembodiments and modifications thereto, which may occur to those who areskilled in the art, are also encompassed by the general conceptsdescribed herein.

As with all cardiac valves, a healthy mitral valve will open to allowblood flow and close to prevent backflow of blood. However, disease anddysfunction of the valve can result in regurgitation or decreased bloodflow. In such cases, a replacement mitral valve prosthesis must be usedto perform the functions of a healthy mitral valve.

However, there are numerous challenges in providing a replacement mitralvalve prosthesis. For example, in order to overcome the problem ofregurgitation or decreased blood flow, a suitable replacement mitralvalve prosthesis must provide an acceptable seal against the nativemitral valve tissue when positioned and released against the nativemitral valve and the mitral annulus. Further, the architecture of themitral annulus, including the aortic-mitral curtain, also creates achallenge in the design of a mitral valve prosthesis. Indeed, the mitralvalve prosthesis must conform to the unique anatomical structure of themitral valve and remain anchored in the presence of the continuouscontractions of a functioning heart.

The present disclosure describes devices and methods for implanting amitral valve prosthesis using a minimally invasive surgical technique.The devices accommodate the complex structure of the mitral valve toensure that the implanted prosthesis is properly positioned and securelymaintained in place after implantation. Further, some embodiments alsoprovide a mitral valve prosthesis delivery system that can comprise adelivery device and a mitral valve prosthesis.

The mitral valve prosthesis can comprise an anchoring element and avalve component coupled to the anchoring element. The valve componentcan have a plurality of prosthetic valve leaflets attached to aninternal surface thereof that can mimic the function of a native mitralvalve. The valve component and anchoring element can have a compactconfiguration for delivery to a diseased valve, and an unfolded orexpanded configuration upon release and implantation in the diseasedvalve annulus.

Moreover, in some embodiments, the valve component and the anchoringelement can be positioned within the delivery system in a serialconfiguration rather than overlapping, thereby reducing the diameter ofthe valve component during delivery.

Further, in some embodiments, the valve component can be flexiblycoupled to the anchoring element to provide efficient positioning ofboth the anchoring element and the valve component. For example, thevalve component and the anchoring element can be connected by a flexibleelement such that prior to releasing and expanding the valve componentin the heart or native valve annulus, the valve component and theanchoring element can be longitudinally or rotationally displacedrelative to one another. Further, the valve component and the anchoringelement can unfolded or expand from a compact state to an expandedstate, and in some embodiments, independently of each other.

Cardiac Valve Anatomy and Valve Replacement

FIG. 1 illustrates a diagrammatic cross-sectional view of a human heart10. The heart 10 can comprise a right atrium 12, a right ventricle 14, aleft ventricle 16, and a left atrium 18. Oxygen-depleted blood entersthe right atrium 12 through the superior and inferior vena cava 20, 22.The oxygen-depleted blood is pumped from the right atrium, through atricuspid valve 24, which separates the right atrium 12 from the rightventricle 14, and into the right ventricle 14. The right ventricle 14then pumps the oxygen-depleted blood through a pulmonary valve 26 andinto pulmonary arteries 28 that direct the oxygen-depleted blood to thelungs for oxygen transfer to the oxygen-depleted blood. Thereafter,oxygen-rich blood is transported from the lungs through pulmonary veins30 to the left atrium 18. The oxygen-rich blood is pumped from the leftatrium 18 through a mitral valve 32 and into the left ventricle 16. Theleft ventricle 16 then pumps the oxygen-rich blood through an aorticvalve 34 and into the aorta 36. The oxygen-rich blood is carried by theaorta to a series of arteries that transport the blood to various organsin the body.

The mitral valve 32, also known as the bicuspid valve or leftatrioventricular valve, opens and closes to control the flow of theoxygen-rich blood from the heart. When the left ventricle 16 relaxes,blood from the left atrium 18 fills the left ventricle 16. When the leftventricle 16 contracts, the increase in pressure within the ventricle 16causes the mitral valve 32 to close, preventing blood from leaking tothe left atrium 18 and assuring that all of the blood leaving the leftventricle 16 is ejected through the aortic valve 34 into the aorta 36and to the body.

FIGS. 2-4 illustrate partial cross-sectional views of the heart 10having a mitral valve prosthesis 50 implanted therein to replace thenative mitral valve 32. FIG. 2 is an enlarged view to illustrate themitral valve 32 of the heart 10, while FIG. 3 illustrates a bottom orventricular view across a valvular plane of the heart 10 and FIG. 4illustrates a top or atrial view of the mitral valve 32. In accordancewith some embodiments, the mitral valve prosthesis 50 can comprise ananchoring element 52 and a valve component 54. The anchoring element 52can anchor to (or engage with) the natural architecture of the nativemitral valve 32 and surrounding tissue, and the valve component 54 cancomprise a plurality of leaflets that function to provide one-way flowof blood through the mitral valve 32.

For example, on the ventricular side (illustrated in FIGS. 2 and 3), theanchoring element 52 can engage with chordae tendineae 60 that extenddownwardly from the mitral valve 32 to anchor on lateral and medialpapillary muscles 62. Further, in some embodiments, the anchoringelement 52 can engage with a mitral annulus 80 of the mitral valve 32.The mitral annulus 80 is a fibrotic ring that has an anterior part and aposterior part. The mitral annulus 80 extends around a perimeter of themitral valve 32. The mitral annulus 80 is a three-dimensionalsaddle-shaped structure (hyperbolic paraboloid) with highest pointsformed by an anterior annulus 82 and a posterior annulus 84, and nadirsat posterolateral and anteromedial commissures 86, 88. The mitralannulus 80 is approximately adjacent to an aortic valve annulus 90.Between the mitral annulus 80 and the aortic valve annulus 90 is anaortic-mitral curtain 92, which is a fibrous structure that connects theanterior annulus 82 of the mitral annulus 80 intimately with the aorticvalve annulus 90 and ends at both lateral sites (adjacent theposterolateral and anteromedial commissures 86, 88) of the mitral valve32 to form the left and right fibrous trigones 94, 96.

Mitral Valve Prostheses

Referring now to FIGS. 5-8B, a mitral valve prosthesis 100 andcomponents thereof are shown in various configurations. The mitral valveprosthesis 100 can comprise a valve component 110 and an anchoringelement 120 to which the valve component 110 is coupled. In someembodiments, the valve component 110 can be flexibly coupled to theanchoring element 120 via a coupler component 122 that is attached atone end to the anchoring element 120 and at the other end to the valvecomponent 110. The coupler component 122 is shown in FIG. 5 as aplurality of threads 124 a, 124 b, 124 c. As discussed herein, theflexible interconnection of the valve component 110 to the anchoringelement 120 can provide advantages in delivering, placing, and ensuringproper function of the mitral valve prosthesis 100.

FIG. 5 also illustrates that in some embodiments, the anchoring element120 can comprise one or more supports, loop structures, wire componentsthat are interconnected with each other by at least one flexibleconnector 140. The flexible connector 140 can comprise at least onesheet, tubular member, or strands of material that are couple two ormore components of the anchoring element 120. For example, the flexibleconnector 140 illustrated in FIG. 5 can comprise a tubular skirtstructure that is coupled at an upper portion to an upper support 150 ofthe anchoring element 120 and at a lower end to a lower support 152 ofthe anchoring element 120. Additional details on the upper and lowersupports 150, 152 are discussed further below.

FIG. 5 illustrates the valve prosthesis 100 in a decoupledconfiguration, in which the valve component 110 is not longitudinallyoverlapping the anchoring element 120, but instead is longitudinallyspaced apart from and adjacent to the anchoring element 120, along acentral or longitudinal axis 142 of the valve prosthesis 100. Thedecoupled configuration is shown to illustrate that the anchoringelement 120 can be placed within the mitral valve, i.e., within theheart between the left ventricle and the left atrium, and secured inplace before the valve component 110 is released and positioned withinthe mitral valve. Additionally, as discussed herein, coupler component122 can facilitate engagement and alignment between the valve component110 and the anchoring element 120, which can allow the valve component110 and the anchoring element 120 to be independently unfolded orexpanded, positioned relative to the structure of the heart, andreleased. Accordingly, as discussed herein, various advantages can beachieved during the surgical procedure.

FIG. 6 illustrates the mitral valve prosthesis 100 in an assembledconfiguration in which the valve component 110 is positioned andexpanded within the anchoring element 120, as would be the configurationafter mitral valve prosthesis 100 is implanted in the native valveannulus of a patient. After the anchoring element 120 has been expandedand positioned within the mitral valve, the valve component 110 can bepositioned and expanded within the anchoring element 120. In someembodiments, during implantation of the valve prosthesis 100, the valvecomponent 110 is expanded only after it has been placed in a positionthat is at least partially longitudinally overlapping and/or concentricwith the anchoring element 120. Thus, the anchoring element 120 can becoupled to the valve component 110 such that the valve component 110 canmove from a position that is longitudinally spaced apart from orserially displaced from the anchoring element 120 to a position at leastpartially longitudinally overlapping or fully concentric to theanchoring element 120.

Anchoring Elements

As noted above, the anchoring element 120 can comprise variouscomponents. For example, the anchoring element 120 can comprise upperand lower supports 150, 152 that are coupled together via the flexibleconnector 140. The upper support 150, the flexible connector 140, andthe lower support 152 can each provide advantages and benefits to thefunction and adaptability of the mitral valve prosthesis 100.

Referring now to FIGS. 7A and 7B, the upper support 150 can comprise astructure that, when seen in a two-dimensional top view, optionally hasa “D” shape (or of a ring having one or more straight sides). Thus, whenseen in a top view, the upper support 150 can comprise a posteriorportion 160 that comprises a semicircular shape and a straight anteriorportion 162, coupled to the posterior portion 160. In geometric terms,the posterior portion 160 can comprise a rounded portion of a ring whilethe anterior portion 162 comprises a chord extending between ends of therounded portion of the ring (opposing ends 164, 166 of the posteriorportion 160) to create a flat or straight side of the ring.

For example, the upper support 150 can comprise a closed D-ring that hasa released, deployed, or unfolded condition that can have anapproximately oval or spherical shape. The radius of the D-ring, whenunfolded, can be sufficient to exert pressure against tissue in the leftatrium and adjacent to the native mitral valve annulus. The D-ring cantake on a saddle shape to conform to a healthy native mitral valveannulus and the presence of the flattened portion of the D-ringaccommodates the stiff structure of the aortic-mitral curtain.

Optionally, when unfolded, the posterior portion 160 of the uppersupport 150 can be substantially planar, i.e., extend within a firstplane. Thus, the length of the upper support 150 extending between theopposing ends 164, 166 can lie in the first plane. There, the posteriorportion 160 can comprise a have first radius of curvature.

Further, the anterior portion 162 of the upper support 150 canoptionally bend out of the first plane, along an axis extendingtransverse relative to the central axis 142 of the valve prosthesis 100.For example, the anterior portion 162 can bow upwardly in an arcuatepath between the opposing ends 164, 166. The arcuate path of theanterior portion 162 can comprise a segment of a circle or have a secondradius of curvature. In some embodiments, the anterior portion 162 canextend and then arcuate path within a second plane, transverse to thefirst plane. For example, the second plane can extend at an angle ofabout 90 degrees relative to the second plane, an angle of between about20 degrees and about 90 degrees relative to the second plane, at anangle of between about 30 degrees and about 80 degrees relative to thesecond plane, an angle of between about 40 degrees and about 70 degreesrelative to the second plane, or an angle of between about 50 degreesand about 60 degrees relative to the second plane.

In some embodiments, the upper support 150 can comprise two, three ormore engagement lobes that enable the upper support 150 to be seatedagainst the mitral valve annulus when implanted in a heart. For example,in some embodiments, the upper support 150 can optionally comprise athree-dimensional, “saddle shape” when unfolded. For example, the uppersupport 150 can comprise a posterior lobe 170 and an anterior lobe 172.Further, the saddle shape of the upper support 150 can also compriselateral lobes 174, 176, extending from the opposing ends 164, 166,between the posterior and anterior lobes 170, 172. When unfolded, asshown in FIG. 7B, the posterior and anterior lobes 170, 172 can bendupwardly relative to the lateral lobes 174, 176. Further, the laterallobes 174, 176 can extend downward from the anterior lobe 172 at anangle of between about 25 degrees to about 55 degrees, an angle ofbetween about 30 degrees to about 50 degrees, or an angle of betweenabout 35 degrees to about 45 degrees relative to the native valveannulus 80 (e.g., relative to a mitral plane or a plane defined bypoints at the opposing ends 164, 166 and an apex of the posterior lobe170). As a result, the anterior lobe 172 can be configured to pushagainst the atrial wall next to the aorta, e.g., press against theaortic-mitral curtain, when implanted within a heart. Further, thelateral lobes 174, 176 can press against the ventricular wall adjacentto and posterior to the mitral valve annulus. Thus, when seen from aside view as in FIG. 7B, the upper support 150 can have a saddle shapethat can be configured to conform to the native mitral valve structure.

The upper support 150 can thus be designed in shape to conform to theanatomy of the native mitral valve annulus 80 while the lower support152 can, in some embodiments, anchor the anchoring element 120 withinthe mitral valve, i.e., within the heart between the left ventricle andthe left atrium. The lower support 152 can comprise a wire frame bodyhaving a substantially round shape when seen in top view, as in FIG. 8A.The lower support 152 can comprise a plurality of lobes, e.g., two,three, four or more (shown as lobes 180, 182, 184 in FIG. 8B) thatextend upwardly along the central axis 142 and a plurality of engagementsections, which can correspond to the number of lobes, e.g., two, three,four or more (shown as engagement sections 190, 192, 194 in FIGS. 8A and8B) interposed between the lobes 180, 182, 184. Thus, according to someembodiments, the lower support 152 can comprise two, three or more lobeswhich, when the lower support 152 is in an expanded condition, extendsuch that each of the lobes exerts pressure against tissue in the leftventricle and adjacent to the native mitral valve annulus.

In accordance with some embodiments, the lower support 152 can comprisea plurality of engagement members 200, 202, 204, shown as hookstructures, each extending from the lower support 152 at a respectiveone of the plurality of engagement sections 190, 192, 194. For example,the lower support 152 can comprise one or more engagement memberspositioned between two lobes. The term “hook” or “hook structure” is notintended to limit the shape or conformation of the hook element as usedherein. The term “hook” or “hook structure” can refer to a structurethat may be attached to the lower support 152 and which can radiallyexpand to form a contact with or partially or fully insert into tissuepresent in the left ventricle and/or near the mitral valve. The hook canbe fabricated from a shape memory metal or from any biocompatiblematerial which remains intact in the heart for several years afterimplantation. Optionally, the engagement members 200, 202, 204 can bespaced apart from each other in a manner that allows the engagementmembers 200, 202, 204 to engage with specific aspects of the nativemitral valve anatomy. Further, optionally, some or all of the engagementmembers or hooks can be covered with a fabric or suture material inorder to reduce or eliminate risk of irritation and scar tissue buildup(see e.g., FIGS. 10A and 10B).

For example, in some embodiments, the lower support 152 can comprisethree lobes and three hooks. A first hook 200 can be positioned betweenthe first and second lobes 180, 182. The second hook 202 can bepositioned opposite, spaced apart by the second lobe 182, from the firsthook 200. Optionally included, the third hook 204 can be positionedmidway between the first and second hooks 200, 202, between the firstand third lobes 180, 184.

In accordance with some embodiments, each of the hooks 200, 202, 204 canextend below a plane of the lower support 152 and hook upwardly towardthe valve annulus when expanded radially within the left ventricle ofthe heart, below the mitral valve annulus. For example, in someembodiments, the hooks can each engage with the mitral valve annulus,the papillae, and/or the ventricular wall to further anchor the lowersupport 152 within the heart between the left ventricle and the leftatrium. Each hook can extend approximately distally such that whenimplanted in a native valve annulus, the free ends of the hooks pointagainst the direction of blood flow. However, in some embodiments, thefree ends of the hooks can point in the direction of blood flow. Thehooks 200, 202, 204 can each comprise a self-expandable shape memorymaterial and positioned to facilitate engagement of the hooks 200, 202,204 with structures in the native mitral valve or left ventricle,including the left ventricular wall. In some embodiments, the lowersupport 152 can comprise more than three hooks, positioned to facilitateengagement of the hooks with structures in the native mitral valve orleft ventricle, including the left ventricular wall. In someembodiments, as the hooks 200, 202, 204 of the lower support 152 canexpand toward the chordae tendineae during valve prosthesis delivery,their design with shape memory metal allows them to expand and hookbetween and/or around the chordae tendineae. Optionally, the hooks ofthe lower support 152 can be pulled toward the chordae tendineae duringvalve prosthesis delivery, their design with shape memory metal allowsthem to expand and hook between and/or around the chordae tendineae.

The upper and lower supports 150, 152 can be fabricated from shapememory material (e.g., a nitinol wire) which is pliable enough toconform to native heart structures during implantation or during bothrotational and lateral positioning of the upper and lower supports 150,152. For example, the upper and lower supports 150, 152 can eachcomprise a self-expanding shape memory wire material. The wire materialcan have a diameter ranging from about X mm to Y mm. In someembodiments, the upper support 150 and/or the lower support 152 cancomprise two or more windings, wrappings, or loops of wire material.

The upper and lower supports 150, 152 can be constructed to providesufficient radial force and strength to prevent or minimize movement ofthe anchoring element 120, and in embodiments that use a valvecomponent, which can be independently expanded and released into thenative valve after implantation of the anchoring element 120. Afterdelivery of the anchoring element 120 to the native valve annulus, boththe upper support 150 can be unfolded to expand within the left atrium,after which the lower support 152 can be pulled into the left ventriclewhile the upper support 150 is maintained within the left atrium. Afteradjusting and releasing the lower support 152, the upper support 150thus remains in the left atrium and the lower support 152 remainsanchored in the left ventricle. The structure of the upper support 150can impart a low profile to the anchoring element 120 so that when it isreleased and implanted within the left atrium, there is minimal or noobstruction to the openings of the pulmonary veins (ostia venarumpulmonalium), yet the anatomical configuration or shape of the uppersupport 150 in its unfolded or expanded condition can provide pressureagainst the atrial walls sufficient to facilitate anchoring of theanchoring element 120 within the native mitral valve annulus.

Referring again to FIGS. 5 and 6, the upper and lower supports 150, 152can be coupled together by the flexible connector 140. In accordancewith some embodiments, the flexible connector 140 can comprise one ormore strands of material or tubular skirt structure. For example, FIGS.5 and 6 illustrate that the flexible connector 140 can comprise a fabricor mesh material (shown as a “skirt” or tapered tubular member) that iscoupled at an upper end portion to an upper support 150 of the anchoringelement 120 and at a lower end to a lower support 152 of the anchoringelement 120. The flexible connector 140 can provide a resilient,stretchable, flexible connection between the upper and lower supports150, 152 that can facilitate alignment between aspects of the upper andlower supports 150, 152 and serve to mitigate or prevent paravalvularleakage after completion of the implant procedure. In some embodiments,the flexible connector 140 can comprise a material including, but notlimited to, elastomeric fabrics, stainless steel alloys, shape memoryalloys, superelastic alloys, knit fabrics, and/or sutures.

In some embodiments, the use of the flexible connector 140 providesadditional benefits in that it permits the use of separate upper andlower supports 150, 152 that can be independently released and expandedwithin the respective ones of the left atrium and left ventricle. Asdiscussed further herein, the upper support 150 can be released withinthe left atrium and pulled downwardly against the mitral annulus as thelower support 152 is drawn downwardly into and expanded within the leftventricle. Because the upper support 150 is coupled to the lower support152 via the flexible connector 140 and can be released independently ofthe lower support 152 in some embodiments, the rotational alignment ofthe upper support 150 relative to the mitral annulus can be more easilyadjusted before expanding the lower support 152, whose engagementstructures may otherwise tend to restrict rotational adjustment of theanchoring element 120. Thereafter, the flexible connector 140 can tendto exert a chronic collapsing force between the upper and lower supports150, 152 that can cause the upper and lower supports 150, 152 to bechronically biased toward each other, thus enhancing engagement of boththe upper and lower supports 150, 152 with the mitral valve anatomy.

Optionally, aspects of the upper and lower supports 150, 152 can berotationally aligned relative to each other in an expanded, defaultstate when coupled to the flexible connector 140. In accordance withsuch embodiments, if the upper and lower supports 150, 152 are rotatedrelative to each other from the default state, such movement will causetension and tensile stress to be exerted on the flexible connector 140.Thus, if the upper and lower supports 150, 152 are rotated relative toeach other in either direction about the central axis 142, the flexibleconnector 140 will want to release torsional stress by re-aligning theupper and lower supports 150, 152 to the alignment in the default state.Thus, during delivery of the anchoring element 120, the upper and lowersupports 150, 152 can tend to re-align relative to each other if theyare rotated relative to each other. Further, in accordance with someembodiments, the relative positioning of the aspects of the upper andlower supports 150, 152 in the default state can be configured to ensurethat aspects of the upper and lower supports 150, 152 tend to beproperly positioned relative to mitral valve anatomy when the positionof one or the other of the upper or lower supports 150, 152 is adjustedduring delivery.

For example, as illustrated in FIGS. 5 and 6, in the default state,opposing ends 164, 166 of the upper support 150 can be rotationallyaligned with the hooks 200, 202 of the lower support 152. As such, asdiscussed above, when the anterior lobe 172 is aligned with theaortic-mitral curtain, the hooks 200, 202 can tend to engage with tissueimmediately below the anteromedial and posterolateral commissures 88,86. For example, in some embodiments, the anterior lobe 172 (illustratedas extending through a plane in the top view of FIG. 7A) can be alignedwithin less than 20 degrees, within less than 15 degrees, within lessthan 12 degrees, within less than 10 degrees, within less than 8degrees, or within less than 5 degrees of a line or plane of theaortic-mitral curtain 92 (e.g., as illustrated by the dashed line 92 inFIG. 4). Thus, in some embodiments, the plane of the flat face of theanterior lobe 172 can land within about 10 degrees of the plane of theaortic-mitral curtain 92 to provide a satisfactory seal between theprosthesis 100 and the surrounding valve structure.

Additionally, in accordance with some embodiments, the flexibleconnector 140 can provide a fluid impervious seal to mitigate or preventparavalvular leakage after completion of the implant procedure. Theflexible connector 140, as discussed above, can comprise a fabric skirtthat extends continuously between and about the perimeters of the upperand lower supports 150, 152. Accordingly, when the upper and lowersupports 150, 152 are securely fastened against and oppose the structureof the native mitral valve, the flexible connector 140 can tend toensure that blood flow does not occur other than through the lumenformed within the flexible connector 140 itself. Accordingly, blood willflow through the mitral valve prosthesis 100, thus avoiding paravalvularleakage, when in some embodiments, the valve component 110 is expandedwithin the lumen of the flexible connector 140.

Further, in accordance with some embodiments, the anchoring element 120can be implanted in a patient without subsequent implantation of a valvecomponent such that the complex performs a function similar to that ofan annuloplasty ring.

The two-ring design of the anchoring element 120 of some embodimentsdisclosed herein advantageously permits the anchoring element 120 to bedeliverable to a target location within the body, reliably disengagefrom a delivery system, and securely engage with the mitral annulus.Applicant has performed several studies and tested many iterations ofthe anchoring element. Various initial designs were shape set usingdifferent thicknesses of superelastic nitinol wire. However, regardlessof the early changes, many problems in still persisted in delivery anddisengagement of the anchoring element from the delivery system.Eventually, a two ring design was developed. The two-ring designachieves the same functions as the other initial designs, but eliminatedmany of the problems that were encountered.

For example, the upper support (or “top ring”) can conform to the nativesaddle-shaped annulus to form a seal against the endocardium, as well ascreates an anchor from the atrial side. The upper support can be madefrom shape set 0.020″ nitinol wire. The upper support can comprise a “D”shape nitinol structure. The lower support (or “bottom ring”) cancomprise another nitinol ring having hooks formed thereon. The lowersupport can be connected to the upper support via a flexible connectoror tubular skirt. The three hooks of the lower support can be positionedabout 120 degrees from one another to latch onto both commissures andthe P2 scallop of the native valve to create anchoring points from theventricular side. The upper and lower supports can be connected via thetubular skirt.

In some embodiments, during delivery, the upper support will not berestrained by graspers or anchor controls of the delivery system, thusallowing the upper support to open more fully, and in some embodiments,can have a larger diameter or size than the lower support. Because theupper support can be more fully open, the anchoring element can providea surer fit against the mitral annulus, improving seal. This can alsoimprove the upper support's ability to anchor while the physician pullsthe anchoring element proximally against the mitral annulus. Further,because the two rings of the anchoring element are separated by aflexible skirt coupling, they can act independently (e.g., the uppersupport can fully open, and the lower support can be manipulated andallowed to expand and anchor on the native mitral apparatus). Further,the circular shape of the valve prosthesis, when seen from the axialview, creates a seal around the implanted valve component. In varioustests, harvested tissue models were used for benchtop testing to verifyand optimize the form and function of these features.

Further, in some embodiments, the crown shape of the lower support isdesigned to crimp into the delivery sheath in a uniformed manner. Duringimplantation, the upper support can first deploy in the atrium beforepositioning and releasing the lower support. This two-step deployment ismore robust and easier to control. The arch on the flat face of theupper support can advantageously allow the upper support to conform tovariations in size and shape of a patient's annulus, while stillmaintaining a seal against the endocardium.

Finally, in accordance with some embodiments, the tubular skirtconnecting the two subassemblies serves several key purposes. Tensionfrom the fabric on the upper and lower supports ensures that the anchorlocks into position and will not migrate after implantation. Slightelasticity from both the fabric and the native tissue lets the hooksslip into their intended anchor points and then rebound to lock inplace. Further, the tubular skirt can also act as a hemostatic sealaround the prosthetic valve to reduce paravalvular leakage and promoteingrowth after the device has been implanted.

Valve Components

As noted above, in some embodiments, the mitral valve prosthesis 100 cancomprise the anchoring element 120 and the valve component 110. Thevalve component 110 can comprise any of the valve components disclosedin U.S. Pat. Nos. 8,444,689, 8,540,767, 8,366,768, 8,366,767, or U.S.Patent Application No. US 2014/0052240, the entireties of each of whichare incorporated herein by reference; further, the surgical approachesdisclosed therein can be used to deliver any of the valve prosthesesdisclosed herein, according to some embodiments.

As shown in FIG. 5, the valve component 110 can include an expandablevalve frame 210 to which prosthetic valve leaflets can be attached,e.g., to an inner surface of the valve frame 210. The valve frame 210can expand radially to a tubular shape wherein the cross-section iscircular and has an outer or external surface and defines a centralorifice about an axis (the longitudinal axis). The longitudinal axiscorresponds to the inflow-outflow axis. The valve frame 210 can bemanufactured from a self-expanding shape memory metal. The valve framecan comprise a mesh or braided tubular material or be laser-cut from atubular material. In some embodiments, the metal is nitinol. In analternative embodiment, the valve frame 210 may comprise a material thatis not self-expanding, but instead can be expanded by a separatecomponent, e.g., through the use of a balloon catheter.

There may be a plurality of prosthetic valve leaflets attached to theinner surface, each made of a flexible material which mimics theanatomical structure and physiological function of native cardiac valveleaflets. In some embodiments, two or three prosthetic valve leafletsare attached to the inner surface. The prosthetic valve leaflets cancomprise a material selected from the group human, bovine, porcine, orequine pericardium tissue, or aortic root from human, bovine, orporcine. Alternatively, the prosthetic valve leaflets can comprise abiocompatible polymer material. Thus, the valve may be either axenograft or a homograft. It may be beneficial if the material istreated, e.g., with glutaraldehyde, to improve biocompatibility. Thebiocompatible material to be used as valve replacement is usuallyfabricated by fixing the material in glutaraldehyde solution, whichfunctions as a tissue preservative. Although fixation in glutaraldehydemay imply drawbacks in view of biomaterial calcification, glutaraldehydefixation still remains the method of choice for preserving tissue andpreparing it for implantation as a biomaterial. In this connection, maybe beneficial if the valve component is treated with a substance thatprevents calcification, e.g., with dimethyl sulfoxide, or similar.

The valve component 110 can comprise a circular cross section, which canpermit the attached prosthetic valve leaflets to be coupled thereto. Thevalve frame 210 may further comprise a plurality of spikes or barbs onits outer surface. Such barbs help to anchor the implanted valvecomponent within the heart and prevent movement of the implantedprosthesis as the heart contracts during its normal physiologicalfunctioning. The barbs, when present, can be made from a self-expandingshape memory material and can thus adopt a compact or expandedcondition. For example, when the valve component 110 is uncovered andallowed to expand during deployment, the barbs can also expand toprotrude upward, outward, and/or downward.

The valve component 110 may comprise a liner or covering such as afabric or mesh covering, which may be attached to the outer and/or innersurface of the valve frame 210. In some embodiments, the covering can beimpervious to blood or other fluids.

Embodiments of a valve component for use in the mitral valve prosthesisdescribed herein are shown in FIGS. 5-6 (valve component 110), FIGS.10A-10C (valve component 252), and FIGS. 11A and 11B (valve component360).

Coupling Between the Anchoring Element and the Valve Component

In some embodiments that use both anchoring element and a valvecomponent, the anchoring element 120 can comprise a structure separatefrom and/or independently expandable of the valve component 110. In suchembodiments, the anchoring element 120 and the valve component 110 canbe interconnected using the coupler component 122, which can provide arange of free relative movement between the anchoring element 120 andthe valve component 110. In some embodiments, the coupler component 122can be coupled to the upper support 150 and/or the lower support 152.

Referring again to FIG. 5, the coupler component 122 can comprise one ormore thread-like structures. In some embodiments, the coupler component122 can comprise one or more sutures. For example, in some embodiments,the coupler component 122 can comprise one, two, three or morethread-like structures, filaments or fibers, for example, sutures. Thecoupler component 122 can comprise three sutures wherein a first end ofeach of the sutures is attached to the anchoring element 120 and asecond end of each of the sutures is attached to the valve frame 210 ofthe valve component 110. In some embodiments, the sutures, when two ormore are present, are spaced equidistant apart. Because of theinterconnection between the valve component 110 and the anchoringelement 120 created by the coupler component 122, the maximum separationor distance between the valve component 110 and the anchoring element120, when either is pulled in a proximal or distal direction, can bedetermined at least in part by the length of the coupler component 122.

In FIG. 5, the coupler component 122 is illustrated as threads 124 a,124 b, 124 c. For example, the coupler component 122 can comprise one ormore sutures, each connected at its first end to the anchoring element120 and at its second end to the valve component 110. In an alternativeembodiment, the coupler component comprises a flexible member such as apiece of fabric or mesh which is attached to both the anchoring element120 and to the valve component 110. For example, in some embodiments,the coupler component 122 is a continuous material impervious to fluid,which can prevent a paravalvular leak after implantation of theanchoring element 120 and valve prosthesis 100.

In accordance with some embodiments, the coupler component 122 can havea fixed length which determines the range of longitudinal or rotationalmovement that the anchoring element 120 can have relative to the valvecomponent 110. For example, the anchoring element 120 can move along thecentral axis 142 (correlating to the inflow-outflow axis when present inthe native valve annulus) such that it can be apart from the valvecomponent 110 along the longitudinal axis at a distance which is about10% to 100%, 25% to 75%, 33% to 100%, 33% to 66%, 25% to 75% or 50% to75%, or 60% to 70% the length of the valve component 110. The anchoringelement 120 can move along its longitudinal axis to overlap the valvecomponent 110 by 10% to 100%, 25% to 75%, 33% to 100%, 33% to 66%, 25%to 75% or 50% to 75% the length of the valve component 110.

The coupler component 122 can allow rotational movement of the anchoringelement relative to the valve component 110. Thus, despite the presenceof the coupler component 122, the anchoring element can moverotationally with respect to the valve component 110. In someembodiments, the coupler component 122 can rotate freely when the valvecomponent 110 is held steady, wherein the free rotation ranges frombetween about 180 degrees to about 460 degrees, between about 180degrees to about 360 degrees, between about 180 degrees to about 340degrees, between about 180 degrees to about 300 degrees, between about180 degrees to about 280 degrees, or between about 180 degrees to about260 degrees, about the central axis 142.

Optionally, the flexible material connecting the anchoring element 120to the coupler component 122 allows the valve component 110 to be moreeasily alignable within or with respect to a lumen of the anchoringelement 120. Further, some embodiments, the coupler component 122 canenable the valve component 110 to be more easily positioned within aperimeter of the upper support 150 and lower support 152 of theanchoring element 120. The coupler component 122 can also allow thevalve component 110 to stay within a longitudinal distance adjacent orserial to the anchoring element 120 along the longitudinal axis 142. Forexample, prior to and during delivery of the anchoring element 120 tothe native mitral valve annulus, the upper support 150 can be releasedand positioned proximal to the valve component 110. The couplercomponent 122 can impart a limit on both the distance the valvecomponent 110 can be separated from the anchoring element 120 as well asthe position of the valve component 110 relative to the anchoringelement 120 when the valve component 110 is positioned within aperimeter of the anchoring element 120, such as when the anchoringelement 120 is released in a native valve annulus.

The coupler component 122 between the valve component 110 and theanchoring element 120 is important for allowing compact and efficientdelivery and deployment of the valve prosthesis 100 in the native mitralvalve annulus of a patient in need thereof. Specifically, duringdelivery to and prior to deployment in the native valve annulus, theanchoring element 120 and the valve component 110 can be positionedserially to or longitudinally spaced apart from one another. In someembodiments, a lack of overlap between the two during advancement to thetarget location allows the system to have a smaller diameter, forexample, when the valve prosthesis 100 is in its compact conditionduring delivery to the heart through vessels or other openings.Moreover, some embodiments of the valve prosthesis 100 allow thedeployment (release or expansion) and positioning of the anchoringelement 120 within the native valve annulus independently of and priorto positioning and deployment of the valve component 110.

In some embodiments, the coupler component 122 can comprise a tubularstructure, such as a tube of fabric. The tubular structure of thecoupler component 122 can define a first end, which can be fixed orconnected along its entire edge to the entire circumference of theanchoring element 120. The coupler component 122 can define a second endwhich is fixed or connected to the valve component 110. The second endcan be connected to the valve frame 210 at a position such that theattached fabric covers about one-fourth, one-third, one-half, two-third,or three-fourths of the valve component 110 or any range in between. Inan alternative embodiment, the second end of the fabric can be connectedto the valve frame 210 at a position such that the attached fabriccovers the entire surface of the valve component 110. Alternatively, thesecond end of the fabric can be attached to the end of the valvecomponent 110 closest to the anchoring element 120 such that the valvecomponent 110 is not covered by the connector fabric along its side.When the fabric of the coupler component 122 does not cover the valvecomponent 110, there may be a separate fabric-like material covering allor a portion of the valve frame. This separate fabric-like material canminimize or block leakage of blood through the valve component 110(paravalvular leakage).

In some embodiments, the fabric of the coupler component 122 can befabricated from a flexible fabric-like material. This material may bemade from, e.g., a polyester polymer. Fabrics as used herein forflexibly connecting an anchoring element 120 to the valve component 110,are generally known in the art, and may comprise any natural orsynthetic polymer that is biocompatible and suitable as a “jacket” forthe stent framework. Further, the polymers may be coated with amedically active substance or any other substance to influence and/ortreat a condition of a patient at the site of implantation of theprosthesis 100. The medically active substances can, for example,prevent stenosis, accelerate healing of wounds of the inside wall of thevessel, or prevent the development of inflammations. In addition, theanchoring element 120 and/or the valve component 110 may be coated ortreated with medically active substance. In some embodiments, the fabriccan be porous to allow blood flow through the fabric during the valveprosthesis implantation procedure.

Referring now to FIGS. 9A and 9B, an alternative embodiment of theanchoring element 120 can comprise a filler component or skirt 230. FIG.9A illustrates a perspective view of the anchoring element 120 andfiller component 230, while FIG. 9B illustrates a bottom view of theanchoring element 120 and the filler component 230.

In accordance with some embodiments, the filler component 230 canadvantageously act as a filler material that occupies any gap betweenthe mitral annulus and the anchoring element 120 when the prosthesis 100is positioned the patient, thereby enabling the filler component 230 toact as a means to reduce paravalvular leakage. Further, the fillercomponent 230 can also improve the anchorage of valve prosthesis (e.g.,by acting as a valve flap during ventricular contraction.

The filler component 230 can be coupled to the anchoring element 120along an upper region thereof. For example, an upper end region 232 ofthe filler component 230 can be attached to the upper support 150 or toa portion of the flexible connector 140. A lower end region 234 of thefiller component 230 can extend away from the upper end region 232 in adirection toward the lower support 152. The lower end region 234 canextend about a perimeter of the lower support 152. In some embodiments,the lower end region 234 can extend downwardly passed the lower extentof the lower support 152. However, the lower end region 234 can alsoextend to a location interposed between the upper and lower supports150, 152.

The filler component 230 can be formed as a tubular member using any ofthe materials disclosed herein with respect to the flexible connector140 and/or the coupler component 122. In some embodiments, the fillercomponent 230 can be fabricated from a flexible fabric or mesh-likematerial, e.g., a polyester polymer. In some embodiments, the fabric canbe porous to allow blood flow through the fabric during the valveprosthesis implantation procedure. Alternatively, the filler component230 can comprise a fabric-like material that can partially or fullyprevent permeation of blood through the filler component 230. In someembodiments, the filler component 230 can comprise a shape memoryflexible material, such as fabric with in-woven nitinol wires, to helpshape the coupler component 122. Further, the filler component 230 maybe coated with a medically active substance or any other substance toinfluence and/or treat a condition of a patient at the site ofimplantation of the prosthesis 100. The medically active substances can,for example, prevent stenosis, accelerate healing of wounds, or preventthe development of inflammations.

Advantageously then, in accordance with some embodiments disclosedherein, the valve component can be a separate component from theanchoring element and can be flexibly attached thereto via a coupling.Such embodiments therefore make it possible that the anchoring elementand the valve component can be implanted in two separate operations.

Mitral Valve Prostheses Comprising a Single Anchoring Ring

FIGS. 10A and 10B illustrate a valve prosthesis 250 that comprises avalve component 252 and an anchoring element 254, wherein the anchoringelement 254 comprises a single anchoring ring 256. The anchoring ring256 can comprise an anterior lobe 260, a posterior lobe 262, and hooks264, 266, 268 as described above. The valve component 252 and anchoringring 256 are each a self-expanding structure. Mounted on the internalface of the valve component 252 is a plurality of prosthetic valveleaflets (not shown). FIG. 10A show the valve component 252 andanchoring ring 256 as serially displaced from each other along thelongitudinal axis. While FIG. 10A shows the valve component 252 andanchoring ring 256 both in an unfolded or expanded condition, duringactual delivery of the valve prosthesis, the valve component 252 andanchoring ring 256 can be in a compact condition until after theanchoring ring 256 is released, as described in more detail below.

FIG. 10A shows embodiments of an anchoring ring 256 in an expandedcondition and circumferential with the valve component 252, includingposterior lobe 262 and anterior lobe 260 with a first hook 264 and asecond hook 266 positioned at indentations between posterior lobe 262and anterior lobe 260. A third hook 268, which can be present in someembodiments, can be positioned midway on posterior lobe 262. Anembodiment of a coupler component 270 is shown in FIGS. 10A-10C whereincoupler component 270 comprises a tubular fabric attached to bothanchoring ring 256 and the valve component 252. When the valveprosthesis 250 is situated in the native valve annulus, the anchoringring 256 can be positioned external to the valve component 252 such thatthe anchoring ring 256 encircles the valve component 252 and ispartially or fully concentric with the valve component 252 (as shown inFIGS. 10B and 10C). FIGS. 10A and 10B also illustrate that some or allof the hooks 264, 266, 268 can be covered with a fabric or suturematerial 272 in order to reduce or eliminate risk of irritation and scartissue buildup.

FIG. 10C depicts a top view looking downwardly from the left atrium intothe left ventricle of the mitral valve prosthesis 250 situated in anative valve structure 280. The anchoring ring 256 can be flexiblyconnected to the valve component 252 before and during release withinthe native valve annulus 280. However, once released, the hooks 264,266, 268 can be below the native valve annulus 280 and the anterior lobe260 and the posterior lobe 262 can be above the native valve annulus 280(in the left atrium), and the valve component 252 is fully expanded in aradially direction. The valve component 252 can be expanded within andcoupled to the anchoring ring 256 to remain stationary relative to oneanother, thus permitting the valve prosthesis 250 to remainsubstantially stationary relative to the native valve annulus. Thus, asthe heart pumps blood and blood flows through the mitral valveprosthesis 250, prosthetic leaflets of the valve component 252 can moveas does a healthy native valve yet remains situated within the nativevalve annulus 280.

Delivery Systems for the Mitral Valve Prosthesis

Also described herein is a delivery system for, e.g., apical ortranscatheter delivery of a mitral valve prosthesis. The delivery systemcan support a valve prosthesis, wherein the delivery device comprises afirst sheath, a second sheath and a control unit, wherein the firstsheath is distal to the second sheath and the second sheath is distal tothe control unit. In some embodiments, the first sheath can comprise atapered end portion. The first and second sheaths can at least partiallyenclose the valve component and the anchoring element prior to andduring valve prosthesis delivery. It is understood that theconfiguration of the delivery system with respect to the first andsecond sheaths, the valve component, and the anchoring element can beany configuration which allows serial positioning along the longitudinalaxis of the anchoring element and the valve component in a compactcondition during delivery followed by independent release andpositioning of the anchoring element prior to positioning and releasingthe valve component, as described in greater detail below.

Reference is now made to FIGS. 11A-11C, illustrating an embodiment of adelivery system 300 used to deliver and release a valve prosthesis 302,as described herein. The delivery device comprises a first sheath 310and a second sheath 320, which is proximal to the first sheath 310. Thesecond sheath 320 is distal to a control unit (not shown) through whichthe physician controls various components of the delivery system 300.Together, the first and second sheaths 310, 320 can house the valveprosthesis 302 during delivery of the valve prosthesis to a targetlocation within the body (e.g., discussed and shown herein as the mitralvalve annulus).

FIG. 11A shows a configuration of a delivery system 300 prior todelivery and during delivery prior to releasing the valve prosthesis302. The valve prosthesis 302 can be configured to comprise the featuresof the valve prosthesis 100 or the valve prosthesis 250, discussedabove. FIG. 11B shows a configuration of the same delivery system 300during delivery, but after releasing an anchoring element 304 (such asanchoring element 120) and prior to releasing a valve component (such asvalve component 110).

In accordance with some embodiments, as shown in FIGS. 11A and 11B, thedelivery system 300 can comprise a central shaft 330 that extendsthrough the length of the center of the first sheath 310 and the secondsheath 320. The distal end of central shaft 330 can be attached to aninternal surface of the first sheath 310 such that by controllinglongitudinal movement of central shaft 330 (e.g., through pushing orpulling central shaft 330), a physician can control longitudinalmovement of the first sheath 310 independently of the second sheath 320in order to enable movement of the first sheath 310 relative to thesecond sheath 320. In some embodiments, to facilitate delivery of thesystem 300 to the target location, the central shaft 330 can beconfigured to permit the system 300 to move along a guidewire 340, whichcan extend through the length of the center of central shaft 330.

The delivery system 300 can optionally comprise a counter nose cone orvalve seat 350 at the distal end of a valve control line 345. The valveseat 350 can comprise a pair of discs that are spaced apart along thelongitudinal axis and interconnected by a valve control lumen or line345. The valve seat 350 can provide a location or space within which thecollapsed valve component can be supported during delivery and duringrelative movements between the sheaths and the components of theprosthesis. An end surface of the counter nose cone 350 can abut theanchoring element and/or the valve component and maintain the anchoringelement and/or the valve component within either or both of the first orsecond sheaths during delivery. The valve seat 350 can resolve thefriction force of the valve component in the first sheath or nose coneduring loading and delivery. The valve control line 345 can be attachedto the control unit at the proximal end of the delivery system 300,extend through the center of the second sheath 320, and terminate at thevalve seat 350.

The delivery system 300 can comprise at least one grasper or anchorcontrol sleeve 395 a, 395 b, or 395 c, as shown in FIGS. 11A and 11B.The number of anchor control sleeves preferably equals the number ofengagement members or hooks of the anchoring element 304 (e.g., thenumber of engagement members of the lower support as in the valveprosthesis 100). Each of the anchor control sleeves 395 a, 395 b, and395 c can be connected at its proximal end to the control unit. Thedistal end of each of the anchor control sleeves 395 a, 395 b, and 395 ccan enclose or be coupled to a hook of the anchoring element 304. Theinterconnection between the distal ends of the anchor control sleeves395 a, 395 b, and 395 c and the engagement members of the anchoringelement 304 can permit the anchoring element 304 of the valve prosthesis302 to be held in a stationary and/or collapsed position relative to orwithin the second sheath 320. When the second sheath 320 is proximallyretracted relative to the distal ends of the anchor control sleeves 395a, 395 b, and 395 c, the engagement members of the anchoring element 304can be released from the distal ends of the anchor control sleeves 395a, 395 b, and 395 c as the anchoring element 304 expands. Accordingly, aphysician can control longitudinal movement of the anchor controlsleeves to effect longitudinal movement of the anchoring element 304.

In some embodiments of the delivery system 300, as illustrated in FIG.11A, a valve component 360 of the valve prosthesis 302 can be enclosedwithin the first sheath 310 prior to releasing the valve component 360in the native valve annulus. The anchoring element 304 can be enclosedwithin the second sheath 320 (e.g., by the distal end of the secondsheath 320) prior to releasing the anchoring element 304. While FIG. 11Bspecifically shows an anchoring element 304 which comprising a D-ring370 and an anchoring skirt 380 (such as that illustrated in FIGS. 5 and6), the valve prosthesis delivery system 300 having the configurationshown in FIGS. 11A-11C can be functional using an anchoring element suchas that discussed above in FIGS. 10A-10C.

In alternative embodiments of the delivery system 300, the anchoringelement 304 and the valve component 360 can both be enclosed within thesecond sheath 320 prior to and during delivery prior to releasing theanchoring element 304. For example, in some embodiments, the anchoringelement 304 can be distal to the valve component 360 wherein theanchoring element 304 is near the distal end of the second sheath 320and the valve component 360 can be approximately adjacent to theanchoring element 304 (in a serial configuration) and is proximal to theanchoring element 304. In some embodiments of the delivery system 300,the anchoring element 304 and the valve component 360 can both beenclosed within the second sheath 320, with the valve component 360 nearthe distal end of the second sheath 320 and the anchoring element 304being approximately adjacent to the valve component 360 and proximal tothe valve component 360.

In some embodiments of the delivery system, the anchoring element 304can be enclosed within the first sheath 310 and the valve component 360can be enclosed within the second sheath 320 prior to and duringdelivery of the valve prosthesis 302. For example, in some embodimentsof the delivery system 300, both the anchoring element 304 and the valvecomponent 360 can be enclosed within the first sheath 310 and the valvecomponent 360 can be enclosed within the second sheath 320 prior to andduring delivery of the valve prosthesis 302. In this configuration, theanchoring element 304 and the valve component 360 can be approximatelyadjacent to one another (in a serial configuration) and the anchoringelement 304 can be positioned proximal to the valve component 360.

In any of the above configurations of the delivery system 300, thephysician can independently release the anchoring element 304 and thevalve component 360. The anchoring element 304 can be released prior toreleasing the valve component 360.

Also, in any of the above configurations of the delivery system 300, theanchoring element 304 can optionally be manipulated after deploymentnear the native valve annulus. For example, after releasing theanchoring element 304 from the delivery system 300, each of the hooks ofthe anchoring element 304 can be releasably or reversibly connected toan anchor control sleeve 395 a, 395 b, and 395 c (e.g., a hook isenclosed by an anchor control sleeve 395 a, 395 b, and 395 c) and thephysician can move the anchoring element 304 along either the rotationalor longitudinal axis in order to properly position the anchoring element304 within the native valve annulus prior to positioning and releasingthe valve component 360.

Prior to releasing the valve prosthesis 302, i.e., before and duringdelivery to the native valve site, the anchoring element 304 and thevalve component 360 can be positioned adjacent to one another along thelongitudinal axis of the delivery system 300. This configuration, asopposed to a concentric arrangement, allows a more radially compactconfiguration of the two pieces of the valve prosthesis 302,facilitating catheter-based delivery.

As discussed herein with respect to other embodiments, the anchoringelement 304 and the valve component 360 can be flexibly connected by atleast one coupler component 352, as shown in FIGS. 11A and 11B. Thecoupler component 352 can be configured as the coupler component 122,discussed above. For example, the coupler component 352 may comprise asuture or other flexible chord that can be connected to both theanchoring element 304 and the valve component 360. In some embodiments,one end of the coupler component 352 can be attached to a fixed positionon the anchoring element 304 and the other end can be attached to afixed position on the valve component 360. In some embodiments, only oneend of the coupler component 352 is attached to a fixed position on theanchoring element 304 or on the valve component 360. Further, in someembodiments, the coupler component 352 can comprise a loop or band ofmaterial that flexibly connects the valve component 360 and anchoringelement 304 without being tied or fixed to single position on either thevalve component 360 or anchoring element 304. In some embodiments, thecoupler component 352 between the anchoring element 304 and the valvecomponent 360 can comprise a fabric material, such as a fabric tube (seee.g., FIGS. 10A and 10B).

The coupler component 352 can comprise any means by which the valvecomponent 360 can move along the longitudinal axis relative to theanchoring element 304 while limiting the maximum distance oflongitudinal movement between the valve component 360 and the anchoringelement 304. In some embodiments, the physician can reach a maximumdistance between the anchoring element 304 and the valve component 360with the valve component 360 being positioned proximal or distal to theanchoring element 304. When the coupler component 352 is in this tautposition, the physician can exert additional longitudinal force togently pull the anchoring element 304 in a proximal or distal directionto adjust the position of the anchoring element 304 within the nativevalve. The anchoring element 304 can be positioned with lobes and hooksof its lower support engaged within the left ventricle and the uppersupport or D-ring positioned within the left atrium. When the anchoringelement 304 comprises an anchoring ring as described above in FIGS.10A-10C, the anchoring element 304 can be positioned within the nativevalve when the hooks are on opposite sides of the annulus such that thehooks are in the left ventricle and the lobes are in the left atrium.When the anchoring element 304 has been properly positioned within thenative valve annulus, the valve component 360, enclosed in either thefirst or second sheath 310, 320, can be moved along the longitudinalaxis toward and to a position within a lumen of or longitudinallyoverlapping the anchoring element 304. In some embodiments, theanchoring element 304 can be positioned at least partially or fullyconcentric to the valve component 360. Accordingly, when positioning thevalve component 360 of the valve prosthesis 302 within the native valveannulus, the valve component 360 can have a fixed range of motion alongthe longitudinal axis. Further, by providing a flexible connection witha calculated and fixed range of movement along the longitudinal axis,the physician can know when the anchoring element 304 and the valvecomponent 360 are spaced apart from each other or properly positioned inrelation to one another. In some embodiments, once the anchoring element304 can move no further due to the coupler component 352, the anchoringelement 304 and the valve component 360 are properly positioned withrespect to each other and the valve component 360 can be released.

Further, in accordance with some embodiments, the anchoring element 304can move freely about its rotational axis while the valve component 360is held steady. This free rotation can occur both before and afterrelease from a sheath and expansion due to the pliable nature of theanchoring element 304. The lobes and hooks can work together tostabilize the anchoring element 304 within the native valve annulus. Forexample, after releasing the anchoring element 304 from a sheath so thatit expands in the left atrium, the physician can move the anchoringelement 304 both longitudinally and rotationally until the appropriatelobe of the anchoring element 304 (e.g., the straight side of the D-ringas viewed from the top, as discussed above) is properly located at theatrial portion of the mitral valve annulus, e.g., with the straight sidebeing aligned with the aortic-mitral curtain.

After releasing the anchoring element 304, the hooks and/or lobesthereof can be expanded and pulled to a position through the annulus (orpulled through the annulus and expanded) to allow contact withstructures such as papillae in the left ventricle. At this time in theimplantation procedure, prior to releasing the valve component 360, theconfiguration and positioning of the anchoring element 304 can preventmovement of the anchoring element 304 towards the left ventricle or leftatrium. For example, when the anchoring element 304 comprises aD-ring-shaped upper support, the upper support can reduce and/or preventmigration of the anchoring element 304 further towards the leftventricle while the lower support can reduce and/or prevent migration ofthe anchoring element 304 towards the left atrium. When the anchoringelement 304 comprises an anchoring ring, the lobes in the left atriumcan prevent movement of the anchoring element 304 further towards theleft ventricle while the hooks in the left ventricle can preventmovement of the anchoring element 304 towards the left atrium.

In some embodiments, the delivery system 300 can deliver a prosthesisthat does not include a valve component. A delivery system having ananchoring element without a valve prosthesis can be used to deliver andimplant only the anchoring element, which may function similarly to anannuloplasty ring.

In some embodiments, the delivery system 300 can deliver a prosthesisthat does not include an anchoring element. Accordingly, treatment of apatient having a mitral valve disorder may comprise first delivering andimplanting an anchoring element as described herein, removing thedelivery system, then separately and subsequently delivering andimplanting a valve component.

Prosthesis Implantation Using a Check Valve

In some embodiments, the delivery system can further comprise a checkvalve that is released temporarily during delivery of the valveprosthesis. Specifically, the check valve can be released and maintainedin an expanded condition after releasing the anchoring element and priorto releasing the valve component. During the time it is expanded, thecheck valve can prevent backflow of blood during the delivery procedureresulting in less stress on the patient's heart. After the valvecomponent is released in the native valve annulus, the check valve canbe compressed and removed from the patient with the delivery device.

For example, FIG. 12 illustrates a delivery system that is being used todeploy a check valve 400. The check valve 400 can be used to minimizeback flow of blood during the valve prosthesis delivery procedure whenthe native mitral valve leaflets are rendered non-functional by thepresence of the delivery system. As shown in FIG. 12, the check valve400 can comprise a check valve frame 410 and a cover component 420. Thecheck valve frame 410 can comprise a self-expanding and/or shape memorymaterial. Further, the check valve frame 410 can be coupled to aplurality of check valve control lines 430 a, 430 b, 430 c that can bemanipulated by the physician to control releasing check valve 400.Further, in some embodiments, the cover component 420 can comprise afabric material that is impervious to fluid.

The check valve 400 can be positioned within the delivery system in acompact condition prior to and during delivery of the valve prosthesis.The check valve 400 can be enclosed within a first sheath 440 or asecond sheath 450 of the delivery system. In some embodiments, prior toreleasing the anchoring element, the check valve 400 can be enclosed inthe second sheath 440. The check valve 400 may be positioned proximallyto, distally to, or concentrically with an anchoring element enclosed inthe second sheath 440 prior to releasing the anchoring element. Afterreleasing the anchoring element, but prior to releasing of the valveframe, the check valve frame 410 can be pushed in a distal direction toexit the distal end of the second sheath 440 and expand accordingly,resulting in the cover component 420 blocking backflow of blood throughthe mitral valve annulus.

In some embodiments, each of the proximal ends of the check valve frame410 can be coupled to the distal end of an anchoring control sleeve(e.g., the anchor control sleeve 395 a, 395 b, and 395 c) so that thecheck valve 400 is released approximately simultaneously with thedeployment of the anchoring element of the prosthesis.

Methods for Implanting a Mitral Valve Prosthesis

Methods for implanting a mitral valve prosthesis using any of theimplantation, delivery, and valve prosthesis devices described hereinmay vary with respect to route of delivery and the anchoring elementused, but all methods may involve minimally invasive transcatheterdelivery and implantation of a mitral valve prosthesis wherein aself-expandable valve component with prosthetic leaflets is flexiblycoupled by a coupler component to a self-expandable anchoring elementand wherein the valve component and anchoring element are delivered in acompact condition, wherein the valve component and anchoring element areserially positioned relative to one-another along a longitudinal axis.

Regardless of the route of administration, the anchoring element can bemanipulated and re-positioned after deployment independently of thevalve component to ensure proper placement. The mitral valve prosthesiscan be implanted over the existing native mitral valve leaflets. Afterproper placement of the anchoring element, the valve component is movedalong the longitudinal axis toward the anchoring element for a distancewhich is determined by the length of the coupler component such that thevalve component is concentric with the anchoring element, at which timethe valve component can be released and the delivery device is removedfrom the patient. The anchoring element is positioned using, in part,imaging such as ultrasound imaging. In some embodiments, the physiciancan feel engagement of the anchoring element in the native valve annulusto facilitate proper positioning of the anchoring element along thelongitudinal axis of the native valve.

Some embodiments of the methods for delivering a mitral valve prosthesisto a defective mitral valve in a patient are shown and discussed withrespect to FIGS. 13-17, which illustrate a method of using a deliverysystem 500 to deliver a mitral valve prosthesis 510. Various embodimentsand features of the delivery system 500 are described above withreference to FIGS. 11A-11C and will not be repeated herein for brevity.

FIGS. 13-19 illustrate a transapical procedure, which can apply to anydelivery method in which the distal end of the delivery system entersthe left ventricle 16 before being advanced through the mitral valveinto the left atrium 18. As shown in FIG. 13, a transapical proceduretypically begins with an apical puncture in the left ventricle 16followed by introduction of a guidewire 504 through the native mitralvalve 32 at least into the left atrium 18. The distal end of thedelivery system 500 in which the valve prosthesis 510 is enclosed isintroduced into the left ventricle 16 through an introducer or trocharplaced in the ventricular wall to create an open path to the mitralvalve 32. However, in some embodiments, other delivery pathways can beused. For example, the distal end of the device can be introduced intothe femoral artery of the patient and advanced through the femoralartery to the aorta, through the aortic valve into the left ventricle 16then through the mitral valve 32 into the left atrium 18.

The delivery device 506 can comprise a first sheath 520, a second sheath530, and graspers or anchor controls 550. The first sheath 520 can becoupled to a tubular member 522 that can extend through the secondsheath 530. Further, the tubular member 522 can comprise a guidewirelumen configured to permit the system 500 to slide along the guidewire504 to the target area. The prosthesis 510 can comprise an anchoringelement 540 and a valve component 570. Whether transapical delivery orotherwise, once the delivery device 506 is positioned within the leftventricle 16, the distal end of the delivery device 506 (including thefirst sheath 520) can be advanced through the defective mitral valve 32and into the left atrium 18 until the portion of the second sheath 530encasing the anchoring element 540 is positioned above the mitral valveannulus 80, as shown in FIG. 13. The second sheath 530 can then bepulled in a proximal direction (away from the left atrium 18) whileholding stationary the first sheath 520, the anchoring element 540, andthe valve component 570 until anchoring element 540 is released from thesecond sheath 530 (as shown in FIG. 14). The physician can adjust theposition of the anchoring element 540 by using the anchor controls 550,which remain releasably or reversibly coupled to anchoring element 540(e.g., via hooks on the anchoring element 540, such as described above).

When the anchoring element 540 comprises the upper and lower supports542, 544, as described above in FIGS. 5-7B, both the upper and lowersupports 542, 544 can unfold and/or radially expand within the leftatrium 18. The anchor controls 550 can be pulled proximally to pull thelobes and hooks of the lower support 544 through the mitral valve 32into the left ventricle 16 while the upper support 542 remains in theleft atrium 18 and the first sheath 520 with valve component 570 remainsstationary. The physician can operate the delivery system 500 by movingthe upper and lower supports 542, 544 rotationally or longitudinally asneeded for proper placement of the upper and lower supports 542, 544 ofthe anchoring element 540.

After the anchoring element 540 has been initially permitted to unfoldor expand within the target area, the physician can then manipulateanchor controls 550 in a proximal direction while the remainingcomponents of the delivery device 506, including the valve component570, can be held stationary until the lower support 544 of the anchoringelement 540 is pulled proximally through the mitral valve annulus 80such that upper support 542 and the lower support 544 of the anchoringelement 540 are on opposite sides of the mitral valve annulus 80. Insome embodiments, the upper support 542 of the anchoring element 540 canbe released only after the lower support 544 is positioned within theleft ventricle 16 and in contact with the tendineae chordae and/or leftventricular wall adjacent to the mitral valve annulus 80.

Once the anchoring element 540 is properly positioned within the valveannulus 80, the first sheath 520 encasing the valve component 570 can bemoved distally (away from the left ventricle 16) a set distance which isdefined by the length and positioning of coupler component 560 (shown inan approximately taut condition and FIGS. 14 and 15). The first sheath520 can then be moved proximally while holding the anchoring element 540stationary until resistance is felt by the operator, indicating that thevalve component 570 is properly positioned within the native valveannulus 80 and relative to anchoring element 540, as shown in FIGS. 15and 16. In some embodiments, the control unit can be programmed orconfigured to include a dial or knob that can move a fixed distanceddependent upon the distance the valve component 570 must be movedrelative to the anchoring element 540 to reach the final position. Thecontrol unit with dial or knob can be configured such that there is ahard stop when the valve is in the correct position relative to theanchoring element 540.

After the valve component 570 has been positioned within a lumen of theanchoring element 540, the first sheath 520 can then be moved in adistal direction while the remainder of the delivery system 500,including anchoring element 540 and the valve component 570, are heldstationary. As a result, the valve component 570 is uncovered and fullyexpands radially within the native valve annulus 80, as shown in FIG.16. In some embodiments, the valve component 570 is released instages—the valve component 570 can be uncovered gradually to allowprogressive and steady radial expansion of the valve component 570. Thisstaged deployment of a valve component 570 can prevent unwantedlongitudinal movement of the valve component 570 relative to theanchoring element 540 and native valve annulus 80. Additionally, thestaged employment can allow some further lateral, proximal movement toproperly position the valve component 570 relative to the anchoringelement 540.

The released valve component 570 can engage with at least the nativeannulus 80, also resulting in further engagement of the engagementmembers or hooks with papillae or the left ventricular wall. If barbsare present on the outer surface of the valve component 570, they canalso engage with structures within and surrounding the native mitralvalve 32 including the native leaflets.

As shown in FIG. 17, the anchor control lines 550 can be disconnectedfrom anchoring element 540 using the control unit to which the proximalend of anchor control 550 is connected. The second sheath 530 can thenbe pushed distally while holding other elements of the delivery device506 stationary until anchor control 550 is fully enclosed by the secondsheath 530, as shown in FIG. 18. The first sheath 520 can then be movedin a proximal direction by pulling the first sheath 520 in a proximaldirection via the first sheath shaft 520 and control unit while keepingthe other elements of the delivery device 506 stationary until theproximal end of the first sheath 520 is adjacent to the distal end ofthe second sheath 530. The delivery device 506 is then removed from thepatient by pulling the delivery device 506 back along the path, leavingthe valve prosthesis 510 properly in place, as shown in FIG. 19.

In some embodiments, the serial positioning of the anchoring elementrelative to the valve component can be manipulated, as can the type orfeatures of the mitral valve prostheses implanted thereby. As topositioning, the valve component may be distal to the anchoring elementsuch that the valve component enters the left ventricle then left atriumahead of the anchoring element during, e.g., a transapical antegradeprocedure or enters the left atrium then left ventricle during, e.g., atransfemoral retrograde procedure. In an alternative embodiment, theanchoring element can be distal to the valve component such that theanchoring element enters the left ventricle then left atrium ahead ofthe valve component during a, e.g., transapical antegrade procedure orenters the left atrium then left ventricle ahead of the valve componentduring a, e.g., transfemoral retrograde procedure. Regardless of therelative positioning of the anchoring element and the valve component,during delivery and prior to implantation, the two structures arepositioned serially rather than concentric or partially concentric toone another thereby reducing the diameter of the valve prosthesis duringdelivery to the native valve annulus. This is particularly important andadvantageous when delivery occurs through the venous system (through anartery and/or vein). Moreover, regardless of the relative positioning ofthe anchoring element and the valve component, the anchoring element andthe valve component can be attached to each other by a coupler componentwhich has a fixed length and which guides placement of the valvecomponent relative to the anchoring element along the inflow-outflowaxis of the native mitral valve annulus.

Further, in some embodiments, the method for delivering the mitral valveprosthesis can further comprises releasing a check valve, as illustratedin FIG. 12. The check valve can reduce or prevent backflow of bloodthrough the mitral valve annulus during the implantation procedure.Accordingly, the method can further comprise, after deployment of theanchoring element, advancing the check valve out of the second sheath toa position in the left atrium wherein the frame of the check valveradially expands resulting in the fabric of the check valve spreadingacross an area which is greater than the area of the mitral valveannulus. The expanded frame can then be moved longitudinally until is itin a position which allows blood to flow from the left atrium to theleft ventricle but does not allow the blood to flow from the leftventricle to the left atrium. Proximal ends of the check valve frame insome embodiments are attached to frame control lines but in someembodiments, the proximal ends of the check valve may be attached to andcontrolled by the anchoring element control sleeves. After implantationof the valve prosthesis, the check valve is removed from the patient aspart of the delivery device.

FIGS. 13-19 merely illustrate some embodiments of a method fordelivering a mitral valve prosthesis as described herein but a deliverydevice can be configured in alternative ways for both antegrade andretrograde delivery and deployment of the valve prosthesis. For example,the anchoring element may be enclosed within the first sheath, which isdistal to the second sheath in which the valve component is enclosed.Accordingly, the first sheath can be advanced through the mitral valvefrom the left ventricle to the left atrium, wherein the first sheath isabove the mitral valve annulus. The anchoring element can then beuncovered and allowed to expand its upper more supports, then pulled ina proximal directed until properly positioned within the valve annulus,as described above. At that time, the second sheath with enclosed valvecomponent can be moved in a distal direction, with the distance moveddependent upon the length of the coupler component as described above.Once properly positioned, the first sheath is moved in a proximaldirection to uncover and release the valve component and the deliverydevice removed from the patient.

The implantation and delivery methods, as well as the valve prosthesisdevices, disclosed herein can also be used in a retrograde approach inwhich the distal end of the delivery system first enters the rightatrium. In a retrograde approach, for example, the valve component canbe enclosed within a distal first sheath while the anchoring element isenclosed within the adjacent proximal second sheath. Accordingly, thefirst sheath is advanced through the mitral valve, partially or fullyinto the left ventricle, so that the second sheath is still within theleft atrium, above the mitral valve annulus. The second sheath is pulledin a proximal direction to uncover the anchoring element, therebyallowing the anchoring element to expand radially. The anchoring elementcan then be advanced through the mitral valve annulus and properlypositioned, optionally using an imaging device, by longitudinal(inflow-outflow axis) and rotational movement. Once the anchoringelement is properly positioned, the first sheath is moved in a proximaldirection until it meets resistance due to the fixed length of thecoupler component. Once properly positioned along the longitudinal, thefirst sheath can be moved distally while holding the valve componentsteady to gradually uncover and release the valve component. Thedelivery device is then removed from the patient.

Retrograde delivery of a mitral valve prosthesis as described herein canalso be performed wherein the anchoring element is enclosed within adistal first sheath while the valve component is enclosed within theadjacent proximal support sheath. Accordingly, the first sheath isadvanced through the aorta into the left atrium to a positionapproximately above the native mitral valve annulus, at which point thefirst sheath is advanced further to uncover and release the anchoringelement. The anchoring element can be partially advanced through themitral valve annulus as described above and the anchoring element can beproperly positioned, optionally using an imaging device, by lateral androtational movement. Once the anchoring element is properly positioned,the second sheath is moved in a proximal direction until it meetsresistance due to the fixed length of the coupler component and thevalve component is gradually uncovered and released within the nativevalve annulus, as described above. The delivery device is then removedfrom the patient. It is understood that use of this method requires thatthe valve component and anchoring element are positioned in each sheathin an orientation opposite that described, e.g., in FIGS. 11A-11C, sothat the anchoring element upper and lower supports and the valvecomponent leaflets are properly oriented in the proper direction toprovide control of blood flow through the mitral valve afterimplantation.

Native Tissue Gathering Components

Some embodiments of the devices and methods disclosed herein canoptionally comprise a native valve seal means that can be incorporatedinto the structure of the device or implemented using a separatecomponent. The native valve seal means can be used to create a tighterand leak-free junction between the mitral valve prosthesis and thenative valve leaflets and/or other native tissue on the ventricularside. The native valve seal means can be implemented or released intothe target area during the initial mitral valve prosthesis implantationprocedure or in a subsequent revision procedure. FIGS. 20A-27 illustratevarious aspects and features of some of the optional embodiments thatcan be implemented to provide a native valve seal means.

For example, FIGS. 20A-21B illustrate embodiments of anchoring elementsthat can comprise optional native tissue gathering structures, accordingto some embodiments. FIGS. 20A and 20B illustrate embodiments of ananchoring element 600, similar to that illustrated above in FIGS. 8A and8B, that can comprise gathering arms 602. The gathering arms can extendupwardly from the hook elements. The hook elements shown in FIGS. 8A and8B, which protrude in a radial and upward direction relative to theanchoring element, can be incorporated into the design illustrated inFIGS. 20A and 20B. However, as shown, the gathering arms 602 can extenddownwardly, continuously, and upwardly from the ends of the anchoringelement 600 in a bend section 604, which can enable the gathering arms602 to be able to deflect in a radial direction away from the centralaxis of the anchoring element 600. Thus, whether an anchoring hook isincorporated into the illustrated design or not, the bend section canallow the anchoring hook 602 to be able to deflect away from the centralaxis in order to permit native tissue, such as valve leaflets, to beinterposed between an inner ring 610 of the anchoring element 600 andthe outer ring 612 formed by the gathering arms 602. In this manner, thenative valve tissue can be sealed around the anchoring element, therebyreducing leakage and regurgitation around the valve prosthesis.

The embodiments illustrated in FIGS. 20A and 20B differ from theembodiments illustrated in FIGS. 21A and 21B in that the embodimentsshown in FIGS. 21A and 21B demonstrate that the gathering arms 602 canbe interconnected (thus, the element numbers for the features of theanchoring element 600 shown in FIGS. 20A and 20B are shared with theelement numbers of the anchoring element 620 shown in FIGS. 21A and21B). For example, in any of the illustrated embodiments, the wireframeof the anchoring elements can comprise a single wire that is wound in acontinuous, unbroken course to create the structure and features of theanchoring element. The ends of the wire can be welded together to formthe continuous, unbroken loop. However, the anchoring elements can alsobe formed using a plurality of independent, separate components that arejoined together by a joining operation, such as welding, adhesives, ormechanical means.

FIGS. 22 and 23 illustrate embodiments of a valve component and ananchoring element of a mitral valve prosthesis 700 in a non-engagedconfiguration, according to some embodiments. These figures illustratestructures otherwise similar to that discussed and illustrated above andFIGS. 5 and six. However, in the illustrated embodiment of the mitralvalve prosthesis 700, the anchoring element 620 is shown as being a wayto gather the flexible connector or tubular skirt of the prosthesis 700toward a central axis of the prosthesis 700. Further, as discussed abovewith regard to FIGS. 20A-21B, the gathering arms of the anchoringelement 620 can not only gather the flexible connector together, but canalso collect and provide a seal between native tissue and the anchoringelement and valve component of the prosthesis 700.

FIGS. 24-27 illustrate features and aspects of another optional nativevalve seal means that can be implemented with a valve prosthesis 720, inaccordance with some embodiments. In these figures, which illustrateaspects of systems discussed already above, which discussion will not berepeated for brevity, a gathering wire 722 can be introduced aroundnative tissue that surrounds the anchoring element of the valveprosthesis 720 after the valve prosthesis 720 has been implanted at thetarget location. The gathering wire can be introduced after the valveprosthesis 720 has been expanded and accommodated in its proper, finallocation. Some implementations of the method can enable a position toposition the gathering wire around the prosthesis 720 with native tissuegathered therebetween, in order to create a tight seal between thenative tissue and an exterior of the valve prosthesis 720. FIG. 24illustrates the gathering wire 722 in a loose state, while FIG. 25illustrates the gathering wire 722 ratcheted or cinched around the valveprosthesis 720. Further, FIG. 26 (similar to FIG. 14 discussed above,the details of which will not be repeated here for brevity) illustratesthe valve prosthesis 720 implanted within the native valve structurewith the native tissue 724 ratcheted or captured between the gatheringwire 722 and the valve prosthesis 720.

FIG. 27 (similar to FIG. 14 discussed above, the details of which willnot be repeated here for brevity) illustrate aspects of the optional useof the gathering wire 722 when deploying a check valve, according tosome embodiments. Further to the discussion of FIG. 14 above, thegathering wire 722 can be used to capture and create a seal betweennative tissue and the check valve when the check valve is deployedduring a procedure. As illustrated, and as possible in any of theembodiments illustrated in FIGS. 24-27, the gathering wire 722 can bedeployed through a separate luminal structure 726 that can extendthrough the sheath of the delivery system.

Illustration of Subject Technology as Clauses

Various examples of aspects of the disclosure are described as numberedclauses (1, 2, 3, etc.) for convenience. These are provided as examples,and do not limit the subject technology. Identifications of the figuresand reference numbers are provided below merely as examples and forillustrative purposes, and the clauses are not limited by thoseidentifications.

Clause 1. A mitral valve prosthesis comprising: an upper support,configured to be positioned adjacent a native mitral annulus of apatient, comprising an anterior portion and a posterior portion; a lowersupport, configured to engage a native mitral valve from a ventricularside, comprising at least two engagement members; a flexible connectorcomprising an upper end portion coupled to the upper support and a lowerend portion coupled to the lower support; and a valve componentcomprising an outer surface and a central orifice, the valve componentbeing disposable intermediate the upper and lower supports, the valvecomponent being radially expandable within the lower support to abut thenative mitral valve and to permit one-way flow therethrough along acentral axis of the prosthesis upon expansion of the valve component;and wherein the lower support and the upper support are radiallyexpandable from a collapsed configuration to an expanded configurationfor delivery within the patient.

Clause 2. The valve prosthesis of Clause 1, wherein the upper supportcomprises a first ring-shaped component.

Clause 3. The valve prosthesis of Clause 2, wherein a top view of thefirst ring-shaped component comprises an approximately D-shapedstructure.

Clause 4. The valve prosthesis of any one of the preceding clauses,wherein in an expanded state, the posterior portion of the upper supportextends within a first plane.

Clause 5. The valve prosthesis of any one of the preceding clauses,wherein the posterior portion of the upper support comprises asemicircular shape.

Clause 6. The valve prosthesis of any one of the preceding clauses,wherein the anterior portion of the upper support bends along an axisextending transverse relative to the central axis.

Clause 7. The valve prosthesis of Clause 6, wherein in an expandedstate, the anterior portion of the upper support extends within a secondplane.

Clause 8. The valve prosthesis of Clause 6, wherein the anterior portionof the upper support comprises a semicircular shape.

Clause 9. The valve prosthesis of any one of the preceding clauses,wherein the posterior portion of the upper support extends within afirst plane and the anterior portion of the upper support extends withina second plane, and wherein the first plane extends transverselyrelative to the second plane.

Clause 10. The valve prosthesis of Clause 9, wherein the posteriorportion comprises a semicircular shape and the anterior portioncomprises a semicircular shape.

Clause 11. The valve prosthesis of any one of the preceding clauses,wherein the flexible connector comprises a tubular shape.

Clause 12. The valve prosthesis of any one of the preceding clauses,wherein the flexible connector comprises a longitudinal length ofbetween about 5 mm and about 25 mm.

Clause 13. The valve prosthesis of Clause 12, wherein the upper supportis moveable within a fixed distance relative to the lower support,wherein the fixed distance being about equal to the longitudinal lengthof the flexible connector.

Clause 14. The valve prosthesis of any one of the preceding clauses,wherein the flexible connector comprises a fabric material.

Clause 15. The valve prosthesis of any one of the preceding clauses,wherein in an expanded state, the flexible connector comprises atapering tubular shape.

Clause 16. The valve prosthesis of any one of the preceding clauses,wherein the valve component comprises a valve frame and a plurality offlexible prosthetic leaflets coupled to the valve frame within thecentral orifice.

Clause 17. The valve prosthesis of Clause 16, wherein the valve framecomprises a self-expanding tubular frame.

Clause 18. The valve prosthesis of Clause 16, wherein the valve framecomprises a balloon-expandable tubular frame.

Clause 19. The valve prosthesis of any one of the preceding clauses,wherein the valve component comprises a cover component extending aboutthe outer surface thereof.

Clause 20. The valve prosthesis of Clause 19, wherein the covercomponent comprises a flexible fabric material.

Clause 21. The valve prosthesis of any one of the preceding clauses,wherein the valve component is coupled to the lower support by at leastone suture member.

Clause 22. The valve prosthesis of Clause 21, wherein the suture membercomprises a length of between about 5 mm and about 25 mm.

Clause 23. The valve prosthesis of any one of the preceding clauses,wherein the lower support comprises a plurality of arcuate sections,each arcuate section extending intermediate respective engagementmembers to form the lower support.

Clause 24. The valve prosthesis of Clause 23, wherein each arcuatesection bends along an axis extending transverse relative to the centralaxis.

Clause 25. The valve prosthesis of any one of the preceding clauses,wherein the lower support comprises a second ring-shaped component, theat least two engagement members being coupled to the second ring-shapedcomponent.

Clause 26. The valve prosthesis of any one of the preceding clauses,wherein the at least two engagement members comprise hooks.

Clause 27. The valve prosthesis of any one of the preceding clauses,wherein the at least two engagement members comprise first and secondhooks, and wherein a distance between the first and second hooks isbetween about 30 mm to about 90 mm.

Clause 28. The valve prosthesis of any one of the preceding clauses,wherein the at least two engagement members comprise three hooks.

Clause 29. The valve prosthesis of any one of the preceding clauses,wherein the at least two engagement members comprise a fabric or suturematerial extending at least partially along surfaces of the engagementmembers.

Clause 30. The valve prosthesis of any one of the preceding clauses,further comprising a filler component coupled to a perimeter of theupper support.

Clause 31. The valve prosthesis of Clause 30, wherein the fillercomponent comprises a tubular shape and an upper end portion coupled tothe perimeter of the upper support.

Clause 32. The valve prosthesis of Clause 30, wherein the fillercomponent comprises a fabric material.

Clause 33. The valve prosthesis of Clause 1, further comprising acoupler component having a first end portion coupled to the anchoringelement and a second end portion coupled to the valve component, thecoupler component restricting a longitudinal displacement between theanchoring element and the valve component.

Clause 34. The valve prosthesis of Clause 33, wherein the couplercomponent comprises a plurality of thread structures.

Clause 35. The valve prosthesis of Clause 33, wherein the couplercomponent comprises a fabric sheet, a suture, or a tubular cloth.

Clause 36. The valve prosthesis of any one of Clauses 33 to 35, whereinthe first end portion of the coupler component is coupled to the uppersupport of the anchoring element and the second end portion of thecoupler component is coupled to a lower portion of the valve component,the coupler component restricting a longitudinal overlap of theanchoring element and the valve component.

Clause 37. A mitral valve prosthesis comprising: an anchoring elementcomprising an upper support, a lower support, and a flexible connector,the upper support being configured to be positioned adjacent a nativemitral annulus of a patient, the lower support being configured toengage a native mitral valve from a ventricular side, the flexibleconnector comprising an upper end portion coupled to the upper supportand a lower end portion coupled to the lower support; and a valvecomponent being coupled to the lower support, the valve component beingradially expandable within the lower support to abut the native mitralvalve.

Clause 38. The valve prosthesis of Clause 37, further comprising anyfeatures of the valve prosthesis of Clauses 1-31.

Clause 39. An valve prosthesis delivery system comprising: a mitralvalve prosthesis comprising an upper support, a lower support, aflexible connector coupling the upper support to the lower support, anda valve component coupled to the lower support, the upper support beingconfigured to be positioned adjacent a native mitral annulus of apatient, the lower support being configured to engage a native mitralvalve from a ventricular side, the valve component being radiallyexpandable within the lower support to abut the native mitral valve; anda delivery device comprising a core member, a first sheath coupled tothe core member, and a second sheath extending over the core member,proximal to the first sheath, wherein the delivery device can maintainthe valve prosthesis in a collapsed configuration with the first sheathenclosing at least a portion of the valve component and the secondsheath encloses at least a portion of the upper and lower supports, andwherein the first and second sheath are movable to expose the upper andlower supports to anchor the valve prosthesis within the patient andthereafter release the valve component within the lower support.

Clause 40. The delivery system of Clause 39, wherein a distal portion ofthe valve component is enclosed by a proximal portion of the firstsheath and a proximal portion of the valve component is enclosed by adistal portion of the second sheath.

Clause 41. The delivery system of any one of Clauses 39 or 40, whereinthe lower support comprises a plurality of engagement members, andwherein the delivery device further comprises a plurality of anchorcontrol components being releasably coupled to the engagement memberswhen the valve prosthesis is in the collapsed configuration.

Clause 42. The delivery system of Clause 41, wherein the plurality ofanchor control components extends longitudinally within the secondsheath.

Clause 43. The delivery system of Clause 41, wherein the plurality ofanchor control components are movable relative to the second sheath.

Clause 44. The delivery system of any one of Clauses 39-43, wherein alower end portion of the flexible connector is attached to the lowersupport and an upper end portion of the flexible connector is attachedto the upper support.

Clause 45. The delivery system of any one of Clauses 39-44, wherein a alower end portion of the flexible connector is attached to the lowersupport and an upper end portion of the flexible connector is attachedto the upper support.

Clause 46. The delivery system of any one of Clauses 39-45, wherein thevalve prosthesis comprises the valve prosthesis of any one of Clauses 1to 33.

Clause 47. A method for implanting a mitral valve prosthesis in a heartof a patient in need thereof, comprising: providing a valve prosthesisdelivery system and a mitral valve prosthesis, the delivery systemcomprising a core member, a first sheath coupled to the core member, anda second sheath extending along the core member, the first sheath beingpositioned distal to the second sheath, the mitral valve prosthesiscomprising an upper support, a lower support, a flexible connectorcoupling the upper support to the lower support, and a valve componentcoupled to the lower support, the first sheath enclosing at least aportion of the valve component, the second sheath enclosing upper andlower supports; the second sheath enclosing at least a portion of theupper and lower supports, the upper support being configured to bepositioned adjacent a native mitral annulus of a patient, the lowersupport being configured to engage a native mitral valve from aventricular side, the valve component being radially expandable withinthe lower support to abut the native mitral valve; inserting at least adistal end portion of the delivery system into the heart of the patient;releasing the valve prosthesis against a native mitral valve annulus ofthe patient; and removing the delivery system from the patient.

Clause 48. The method of Clause 47, wherein the inserting comprisesinserting the distal end portion of the delivery system into a leftventricle of the heart through an opening made in an apex of the heart.

Clause 49. The method of Clause 48, further comprising advancing thedistal end portion of the delivery system into a left atrium of theheart prior to the releasing.

Clause 50. The method of any one of Clause 48 or 49, further comprisingadvancing the first sheath of the delivery system into a left atrium ofthe heart prior to the releasing.

Clause 51. The method of any one of Clauses 47-50, wherein the releasingcomprises proximally retracting the second sheath to permit expansion ofthe upper support and positioning the upper support adjacent a nativemitral annulus of the patient.

Clause 52. The method of Clause 51, wherein the releasing furthercomprises proximally retracting the second sheath to permit expansion ofthe lower support and positioning the lower support against the mitralvalve from a ventricular side.

Clause 53. The method of any one of Clauses 47-52, wherein the releasingcomprises permitting expansion of the upper and lower supports within aleft atrium of the heart and proximally withdrawing the lower supportinto a left ventricle of the heart.

Clause 54. The method of Clause 52, wherein delivery system comprises aplurality of anchor control components coupled to respective engagementmembers of the lower support, and wherein the releasing furthercomprises disengaging the plurality of anchor control components fromthe engagement members to permit the lower support to expand against themitral valve from the ventricular side.

Clause 55. The method of Clause 54, further comprising moving theplurality of anchor control components to reposition the lower supportrelative to the native mitral valve.

Clause 56. The method of Clause 54, further comprising permitting theengagement members to engage with an anterior commissure, a posteriorcommissure, and a posterior leaflet of the native mitral valve.

Clause 57. The method of any one of Clauses 47-56, wherein the releasingcomprises aligning an anterior portion of the upper support with anaortic-mitral curtain of the native mitral valve annulus.

Clause 58. The method of Clause 57, wherein the anterior portion of theupper support extends within a vertical plane and the aligning comprisesaligning the vertical plane within between 0 degrees and 20 degrees of aline representative of an aortic-mitral curtain of the native mitralvalve annulus.

Clause 59. The method of Clause 58, wherein the aligning comprisesaligning the vertical plane within about 10 degrees of the linerepresentative of the aortic-mitral curtain of the native mitral valveannulus.

Clause 60. The method of any one of Clauses 47-59, wherein the releasingcomprises aligning a posterior, semicircular portion of the uppersupport with a posterior annulus of the native mitral valve annulus.

Clause 61. The method of any one of Clauses 47-59, further comprisinggathering native tissue against the prosthesis.

Clause 62. The method of Clause 61, wherein the gathering native tissueagainst the prosthesis comprises positioning a gathering wire around thenative tissue and the prosthesis after release of the prosthesis.

Clause 63. The method of any one of Clauses 61 to 62, wherein thegathering native tissue against the prosthesis comprises engaging agathering arm of the prosthesis with the native tissue.

Further Considerations

In some embodiments, any of the clauses herein may depend from any oneof the independent clauses or any one of the dependent clauses. In someembodiments, any of the clauses (e.g., dependent or independent clauses)may be combined with any other one or more clauses (e.g., dependent orindependent clauses). In some embodiments, a claim may include some orall of the words (e.g., steps, operations, means or components) recitedin a clause, a sentence, a phrase or a paragraph. In some embodiments, aclaim may include some or all of the words recited in one or moreclauses, sentences, phrases or paragraphs. In some embodiments, some ofthe words in each of the clauses, sentences, phrases or paragraphs maybe removed. In some embodiments, additional words or elements may beadded to a clause, a sentence, a phrase or a paragraph. In someembodiments, the subject technology may be implemented without utilizingsome of the components, elements, functions or operations describedherein. In some embodiments, the subject technology may be implementedutilizing additional components, elements, functions or operations.

The foregoing description is provided to enable a person skilled in theart to practice the various configurations described herein. While thesubject technology has been particularly described with reference to thevarious figures and configurations, it should be understood that theseare for illustration purposes only and should not be taken as limitingthe scope of the subject technology.

There may be many other ways to implement the subject technology.Various functions and elements described herein may be partitioneddifferently from those shown without departing from the scope of thesubject technology. Various modifications to these configurations willbe readily apparent to those skilled in the art, and generic principlesdefined herein may be applied to other configurations. Thus, manychanges and modifications may be made to the subject technology, by onehaving ordinary skill in the art, without departing from the scope ofthe subject technology.

It is understood that the specific order or hierarchy of steps in theprocesses disclosed is an illustration of exemplary approaches. Basedupon design preferences, it is understood that the specific order orhierarchy of steps in the processes may be rearranged. Some of the stepsmay be performed simultaneously. The accompanying method claims presentelements of the various steps in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

As used herein, the term “distal” can denote a location or directionthat is away from a point of interest, such as a control unit or regionof the delivery device which will be used to deliver a valve prosthesisto a native valve annulus. Additionally, the term “proximal” can denotea location or direction that is closer to a point of interest, such as acontrol unit or region of the delivery device which will be used todeliver a valve prosthesis.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “and” or “or” to separate any of the items,modifies the list as a whole, rather than each member of the list (i.e.,each item). The phrase “at least one of” does not require selection ofat least one of each item listed; rather, the phrase allows a meaningthat includes at least one of any one of the items, and/or at least oneof any combination of the items, and/or at least one of each of theitems. By way of example, the phrases “at least one of A, B, and C” or“at least one of A, B, or C” each refer to only A, only B, or only C;any combination of A, B, and C; and/or at least one of each of A, B, andC.

Terms such as “top,” “bottom,” “front,” “rear” and the like as used inthis disclosure should be understood as referring to an arbitrary frameof reference, rather than to the ordinary gravitational frame ofreference. Thus, a top surface, a bottom surface, a front surface, and arear surface may extend upwardly, downwardly, diagonally, orhorizontally in a gravitational frame of reference.

Furthermore, to the extent that the term “include,” “have,” or the likeis used in the description or the claims, such term is intended to beinclusive in a manner similar to the term “comprise” as “comprise” isinterpreted when employed as a transitional word in a claim.

The word “exemplary” is used herein to mean “serving as an example,instance, or illustration.” Any embodiment described herein as“exemplary” is not necessarily to be construed as preferred oradvantageous over other embodiments.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically stated, but rather “one or more.”Pronouns in the masculine (e.g., his) include the feminine and neutergender (e.g., her and its) and vice versa. The term “some” refers to oneor more. Underlined and/or italicized headings and subheadings are usedfor convenience only, do not limit the subject technology, and are notreferred to in connection with the interpretation of the description ofthe sub7ject technology. All structural and functional equivalents tothe elements of the various configurations described throughout thisdisclosure that are known or later come to be known to those of ordinaryskill in the art are expressly incorporated herein by reference andintended to be encompassed by the subject technology. Moreover, nothingdisclosed herein is intended to be dedicated to the public regardless ofwhether such disclosure is explicitly recited in the above description.

Although the detailed description contains many specifics, these shouldnot be construed as limiting the scope of the subject technology butmerely as illustrating different examples and aspects of the subjecttechnology. It should be appreciated that the scope of the subjecttechnology includes other embodiments not discussed in detail above.Various other modifications, changes and variations may be made in thearrangement, operation and details of the method and apparatus of thesubject technology disclosed herein without departing from the scope ofthe present disclosure. Unless otherwise expressed, reference to anelement in the singular is not intended to mean “one and only one”unless explicitly stated, but rather is meant to mean “one or more.” Inaddition, it is not necessary for a device or method to address everyproblem that is solvable (or possess every advantage that is achievable)by different embodiments of the disclosure in order to be encompassedwithin the scope of the disclosure. The use herein of “can” andderivatives thereof shall be understood in the sense of “possibly” or“optionally” as opposed to an affirmative capability.

What is claimed is:
 1. A heart valve prosthesis delivery systemcomprising: a first sheath having a first lumen; a second sheath,proximal to the first sheath, having a second lumen; a heart valveprosthesis carried within the first sheath or the second sheath, whereinthe valve prosthesis comprises an anchoring element and a valvecomponent having an expandable valve frame, the valve component beingflexibly coupled to the anchoring element via a coupler componentcomprising a sheet member; a check valve carried within the first sheathor the second sheath, the check valve having a check valve frame and acover component, the check valve being configured to be deployed withinnative valve structure for minimizing back flow of blood duringplacement of the valve prosthesis when native valve leaflets arerendered non-functional by the presence of the delivery system, whereinthe check valve is positioned concentrically with the anchoring element;and a plurality of check valve control lines extending within the secondlumen, the plurality of check valve control lines coupled to the checkvalve frame and configured to be manipulated by a physician to controlrelease of the check valve.
 2. The delivery system of claim 1, whereinthe check valve frame is carried within the first sheath in anunexpanded configuration.
 3. The delivery system of claim 1, wherein thecheck valve frame is carried within the second sheath in an unexpandedconfiguration.
 4. The delivery system of claim 1, wherein the anchoringelement and the check valve are positioned within the second sheath inan unexpanded configuration.
 5. The delivery system of claim 1, whereinthe check valve frame is configured to move to an expanded configurationwhile the valve prosthesis is maintained in an unexpanded configuration.6. The delivery system of claim 5, wherein the check valve frame isrelatively movable in a distal direction out of the second sheath tomove to the expanded configuration, the cover component of the checkvalve being expandable to block backflow of blood through the nativevalve structure.
 7. The delivery system of claim 1, wherein the checkvalve frame comprises a self-expanding material.
 8. The delivery systemof claim 1, wherein the check valve frame comprises a shape memorymaterial.
 9. The delivery system of claim 1, wherein the cover componentcomprises a fabric material.
 10. The delivery system of claim 1, whereinthe cover component is impervious to fluid.
 11. The delivery system ofclaim 1, wherein the sheet member comprises a tubular skirt structure.12. A method for implanting a heart valve prosthesis in a heart of apatient in need thereof, comprising: inserting a heart valve prosthesisdelivery system into a native valve structure of a patient, the heartvalve prosthesis delivery system having a first sheath, a second sheaththat is proximal to the first sheath, a heart valve prosthesis carriedwithin the first sheath and the second sheath in an unexpandedconfiguration, wherein the valve prosthesis comprises an anchoringelement and a valve component having an expandable valve frame, thevalve component flexibly coupled to the anchoring element via a couplercomponent comprising a sheet member, and a check valve carried withinthe first sheath or the second sheath, and a plurality of check valvecontrol lines coupled to the check valve; expanding the check valvewithin the native valve structure by manipulating the plurality of checkvalve control lines for restricting back flow of blood through thenative valve structure; after the expanding the check valve, releasingthe valve prosthesis from the delivery system into the native valvestructure, wherein the releasing comprises distally advancing the firstsheath relative to the second sheath and proximally withdrawing thesecond sheath relative to the first sheath to expose the valveprosthesis; withdrawing the check valve into the second sheath; andremoving the delivery system from the patient.
 13. The method of claim12, wherein the expanding comprises proximally retracting the secondsheath to expose the check valve.
 14. The method of claim 12, whereinthe check valve has a check valve frame and a cover component andwherein the plurality of check valve control lines are coupled to thecheck valve frame, and wherein the expanding further comprisesmanipulating the plurality of check valve control lines to interpose thecover component within the native valve structure.
 15. The method ofclaim 12, wherein the valve prosthesis comprises a valve component andan anchoring element, the anchoring element being carried within thesecond sheath.
 16. The method of claim 12, wherein the prosthesiscomprises an anchoring element, and wherein the proximal withdrawal ofthe second sheath expands the anchoring element prior to the distallyadvancing the first sheath.
 17. The method of claim 12, wherein theexpanding the check valve comprises distally advancing the check valverelative to the second sheath to move the check valve to an expandedconfiguration.
 18. The method of claim 12, wherein the anchoring elementcomprises an upper support, a lower support separate from the uppersupport, and a flexible connector, and wherein the releasing comprisespositioning the upper support adjacent to a native valve annulus of apatient and engaging the lower support with the native valve structureto interpose the flexible connector against the native valve structure.19. A heart valve prosthesis delivery system comprising: a first sheathhaving a first lumen; a second sheath, proximal to the first sheath,having a second lumen; a heart valve prosthesis carried within the firstsheath or the second sheath, wherein the valve prosthesis comprises ananchoring element and a valve component having an expandable valveframe, the anchoring element comprising a top ring, a bottom ring, and aflexible connector connecting the top ring to the bottom ring; a checkvalve carried within the first sheath or the second sheath, the checkvalve having a check valve frame and a cover component, the check valvebeing configured to be deployed within native valve structure forminimizing back flow of blood during placement of the valve prosthesiswhen native valve leaflets are rendered non-functional by the presenceof the delivery system, wherein the check valve is positionedconcentrically with the anchoring element; and a plurality of checkvalve control lines extending within the second lumen, the plurality ofcheck valve control lines coupled to the check valve frame andconfigured to be manipulated by a physician to control release of thecheck valve.
 20. The delivery system of claim 19, wherein the flexibleconnector comprises a tubular membrane.
 21. The delivery system of claim19, wherein the flexible connector is connected to an entirety of acircumference of the top ring.
 22. The delivery system of claim 21,wherein the flexible connector is connected to an entirety of acircumference of the bottom ring.
 23. A method for implanting a heartvalve prosthesis in a heart of a patient in need thereof, comprising:inserting a heart valve prosthesis delivery system into a native valvestructure of a patient, the heart valve prosthesis delivery systemhaving a first sheath, a second sheath that is proximal to the firstsheath, a heart valve prosthesis carried within the first sheath and thesecond sheath in an unexpanded configuration, and a check valve carriedwithin the first sheath or the second sheath, and a plurality of checkvalve control lines coupled to the check valve; positioning the deliverysystem within the native valve structure; expanding the check valvewithin the native valve structure by manipulating the plurality of checkvalve control lines for restricting back flow of blood through thenative valve structure; after the expanding the check valve, releasingthe valve prosthesis from the delivery system into the native valvestructure, wherein the releasing comprises distally advancing the firstsheath relative to the second sheath and proximally withdrawing thesecond sheath relative to the first sheath to expose the valveprosthesis; withdrawing the check valve into the second sheath; andremoving the delivery system from the patient.
 24. The method of claim23, wherein the prosthesis comprises an anchoring element, and whereinthe proximal withdrawal of the second sheath expands the anchoringelement prior to the distally advancing the first sheath.